U.S. drug recalls last year soared past the record set in 2009 due to a spike in contamination-related recalls.

As in 2009, most of the spike was from a single repackaging incident. Much of the rest was from one manufacturer’s sale of potentially contaminated antiseptic swabs, pads and wipes. Also, a number of manufacturers had a variety of contamination issues, many of them related to glass containers and plastic bottles.

There was a significant increase in other problem areas as well. Recalls related to potency, dissolution and other specifications such as impurities/degradants, tablet hardness and tablet weight/thickness were double the historical average.

There were 202 recalls in 2011 of products that recallers said were manufactured at facilities outside the U.S.

Some dosage forms bore the brunt of last year’s increase in recalls. The issue with swabs, pads and wipes boosted topical recalls to nearly 16 times the prior 10-year average. The repackaging incident helped push oral solid recalls to five times the historical average, and oral liquid recalls to 3.4 times the average.

Injectables recalls were three times the 10-year annual average due to the same combination of factors that drove them to record levels in 2010 and that have contributed to shortages of critical drug products Also see "Another Busy Year of Drug Recalls Led to Shortages of Injectables" - Pink Sheet, 1 May, 2011..

Additional details appear in tables below and here: ([A#08120328001]).

And for the first time, “The Gold Sheet” is providing a version of the spreadsheet that supports its analysis of the prior year’s drug recalls ([A#08120328009]). Open, download and search the database.

Another spike in drug recalls

Aidapak repackaging incident

Of last year’s 2,329 drug recalls, 1,024 resulted from a single incident, in which Aidapak Services LLC, Vancouver, Wash., realized that penicillin could have cross-contaminated numerous products repackaged in its facility for hospital inpatient pharmacies. Aidapak launched the recall on May 27, following up with a press release on June 1.

When an FDA inspection of Aidapak’s Vancouver facility concluded on Jan. 6, 2011, the agency issued an “official action indicated” finding, the most serious of three possible inspectional outcomes, and one that often presages warning letters, seizures and other enforcement actions. However, FDA has not announced any such actions regarding Aidapak.

It is not clear how the FDA inspection may have been connected to Aidapak’s recall, which occurred six months later. The agency has been pressing for Congress to grant it authority to mandate recalls, which could prevent public exposure to risks when manufacturers resist its suggestions to recall products.

In its June 1 press release, Aidapak asked hospitals, emergency rooms, clinics and other healthcare facilities to quarantine any affected products, which would be stamped with its packaging stamp, and email the company for a returns packet and instructions.

The company added that it “has instituted a complete cleaning and decontamination of our facilities followed by testing by two separate laboratories to ensure the absence of any penicillin or non-penicillin beta-lactam contaminates.”

The incident fell just short of topping the 1,106 recalls that Advantage Dose issued in November 2008 after FDA inspectors found GMP problems at its repackaging facility in Shreveport, La., and raised concerns about cross-contamination risks Also see "Record Drug Recall Totals for 2009 Resulted from GMP Breakdowns" - Pink Sheet, 1 May, 2010..

The incident mirrors repackaging failures at [Pharmaceutical Corp. of America] in 2000 and Heartland Repack Services in 2006, which ultimately led those companies to get out of the pharmaceutical repackaging business, as Advantage Dose later did Also see "Advantage Dose's GMP Issues Mirrored Earlier Problems Affecting Repackers" - Pink Sheet, 1 May, 2010..

Because companies like Aidapak divide pharmaceuticals into unit-dose packages for use in hospitals, repackaging failures can generate large numbers of very small recalls. Hospitals generally provide pharmaceuticals in unit-dose packages to prevent certain types of dispensing errors.

Most hospitals rely on their pharmacies to handle unit-dose repackaging, which typically involves highly manual processes that can be error-prone and can involve double, triple or even quadruple checking. Only about 10% of hospital pharmacies use third-party repackagers due to concerns about cost, turnaround time and quality, a recent survey by the Center for Innovation in Healthcare Logistics at the University of Arkansas in Fayetteville, Ark., found, according to the survey report Also see "Using Third-Party Repackagers Improves Hospital Patient Safety, Experts Say" - Pink Sheet, 1 May, 2010. and an article in the July 2010 issue of the American Journal of Health-System Pharmacy.

H&P Triad wipes

After reports of post-surgical bacterial infections in two children that were believed to be linked to the use of alcohol prep pads that had become contaminated with Bacillus cereus, FDA inspected the pads’ manufacturer, H&P Industries Inc., Hartland, Wis. The inspection ran from Nov. 29, 2010, to Jan. 7, 2011.

H&P, which distributed the products through its Triad Group Inc. unit, began recalling alcohol wipes on Jan. 3, 2011 as the inspection came to a close. Over the next few months, 10 customers recalled products that contained the wipes, including various first aid kits and kits for four injectable drugs: GlaxoSmithKline Inc. ’s Arixtra, EKR Therapeutics Inc. ’s Retavase, Allergan PLC’s Trelstar and Sanofi-Aventis US LLC’s Lovenox.

H&P launched two more recalls on March 15, 2011, for all lots of povidone iodine prep pads due to contamination with Staphylococcus warneri, Stenotrophomas maltophilia and Elizabethkingia meningoseptica. One was a Class II recall for products used in first aid. The other was a Class I recall for products used as antiseptics in surgical preparation. There followed over the next two months and again in the fall a series of povidone iodine prep pad recalls by various H&P customers.

A seizure and plant shutdown in April was followed by an FDA consent decree in June 2011 that governed the plant remediation process. FDA approved H&P’s third reconditioning plan in December. The plan focuses on ingredient reconditioning and destruction followed by a quality systems approach to cGMP compliance and plant re-start.

FDA has published inspectional and reconditioning correspondence with H&P on its web site.

In a Sept. 21, 2011, pharmacovigilance review, FDA said it identified 139 relevant cases in its Adverse Event Reporting System, including 10 fatalities and eight reports of positive cultures. However, the agency concluded that it lacked sufficient information to evaluate 120 of the cases. As for the other 19, FDA determined that a connection to the suspect products was possible, but the agency could not confirm any of them. The Milwaukee, Wis., Journal Sentinel, which has published a series of articles on the case, posted FDA’s review online.

Where the contamination came from

Other contamination recalls

Even after setting aside the 1,024 Aidapak and 293 Triad recalls, there were 248 other contamination-related drug recalls, still four times the prior decade’s annual average.

The year before, there were 168 contamination-related recalls, three times the 2000-2009 annual average.

Of those 248 contamination recalls in 2011, 33 involved issues related to glass containers and 10 involved malodorous plastic bottles in.

The glass-related recalls involved some big players in biotech and generics: Abbott Laboratories Inc., Amgen Inc., AstraZeneca Pharmaceuticals LP, Novo Nordisk Inc., Ortho-McNeil Inc., Centocor Ortho Biotech Services LLC, APP Pharmaceuticals Inc., Hospira Inc., Teva Pharmaceuticals USA Inc. and Paddock Laboratories LLC. Typically they involved things like cracked syringes or the presence of glass flakes.

Makers of injectables recently gathered with glass suppliers and others under the auspices of the Parenteral Drug Association to work on the glass quality issues, which have turned out to be rather complex Also see "Glass Quality Crisis Prompts Multi-Faceted Array of Risk-Based Improvements" - Pink Sheet, 1 August, 2011..

The odor cases involved: Plavix made at Bristol-Myers Squibb Co.’s plant in Humacao, Puerto Rico; simvastatin made at Dr. Reddy's Laboratories Ltd. in Quthbullapur, India; Tylenol caplets from the McNeil Consumer Healthcare plant in Fort Washington, Pa.; Topamax tablets from a Jansen Ortho LLC plant in Gurabo, Puerto Rico; risperidone tablets from Ortho-McNeil Inc.’s plant in Raritan, N.J.; and Lipitor from Pfizer Inc. plants in Ireland, Germany and Puerto Rico. These cases were linked to 2,4,6-tribromoanisole (TBA), a degradant of the chemical wood preservative 2,4,6-tribromophenol (TBP), an issue first seen with McNeil, then Pfizer Also see "Data Integrity Problems Continued to Surface in Recent Warning Letters" - Pink Sheet, 1 February, 2010., Also see "McNeil Expands Tylenol Recall As FDA Criticizes Firm's Response To AERs" - Pink Sheet, 18 January, 2010..

A common thread in many of those cases was production in hot, humid environments.

Recalls involving several organic contaminants were reported: Penicillin Citreonigrum, Streptococcus oralis, Bulkholderia cepacia and mold.

There were also a number of cases involving foreign tablets, a few involving precipitation or crystallization, and a variety of cases of particulate contamination involving stainless steel, polyvinyl chloride, rubber and food grade gasket materials or unspecified materials.

Eleven recalls were associated with a batch carryover issue at Baxter Healthcare Corp.’s plant in Jayuya, Puerto Rico, which spurred a Jan. 20 warning letter Also see "Poor Handling of Complaints, Contractors, Contamination Draw FDA Warning Letters" - Pink Sheet, 1 March, 2011.. Another pair of recalls involved concerns about bacterial endotoxin testing equipment at the same plant.

One case involved shelf life concerns associated with out-of-trend preservative efficacy for Bausch & Lomb Inc. eye drops.

Also, Hospira had some issues with potentially leaky bags.

Sterility concerns played a significant role in the shortages of cancer drugs and other generic injectables that have disrupted patient care in the U.S. over the past couple of years.

Pressure has been building in Congress to come up with legislation to alleviate the shortages, but the discussion has focused on enhancing the shortage alert process and allowing replacement drug imports rather than identifying and attacking the root causes.

FDA has praised generics injectables firms for stepping up production to fill in for competitors hobbled by GMP problems, only to go after those same companies for GMP violations of their own Also see "FDA Drug Shortage Strategy: Enforcement Discretion, Patient Public Relations" - Pink Sheet, 21 February, 2012. Also see "APP Pharmaceuticals, Praised For Easing Drug Shortages, Gets Manufacturing Warning Letter" - Pink Sheet, 5 March, 2012..

Why Ben Venue suspended operations

Last year, FDA and the European Medicines Agency came down hard on Ben Venue Laboratories Inc. of Bedford, Ohio, the manufacturing arm of Boehringer Ingelheim's generic injectables manufacturing unit, Bedford Laboratories.

EMA restricted importation of some medicines from Ben Venue to the European Union as a result of a March 2011 inspection.

FDA produced a 33-page Form 483 report containing 48 inspectional observations after an inspection of Ben Venue that ran from May 2 to May 25, 2011. That inspection involved a team of six investigators, a microbiologist, a chemist and a consumer safety officer.

Four FDA investigators returned to Ben Venue for another inspection that ran from Nov. 7 to Dec. 2, 2011. They were accompanied Nov. 7-11 by inspectors from the French and British drug regulatory agencies.

As a result of the joint inspection, FDA issued another Form 483 report and EMA recommended selective recalls. Based on a risk-based review that the European Commission requested, EMA said for Ben Venue to recall 14 batches of the anti-fungal Ecalta, and one already quarantined batch of the diagnostic medicine Luminity. EMA decided to leave anti-cancer medicines Ceplene and Torisel on the European market, though with a recommendation for healthcare professionals to visually inspect the vials for particulates prior to use.

Also as a result of that inspection, Ben Venue Nov. 19 suspended manufacture and distribution of all drug products from the plant. The company said Dec. 23 that it was extending the suspension, and likely would not start restoring manufacturing lines until sometime in the first quarter of 2012.

The plant's North facility, where Ben Venue was making several sterile injectables that are in short supply, requires major reconstruction that will take at least nine months, the company said.

The concerns at Ben Venue primarily centered on quality management and sterility assurance issues, particularly as they related to aseptic filling processes at Ben Venue's North facility.

Of the company’s seven recalls in 2011, all but one were ranked Class II. The sole Class I recall occurred on April 19, just a couple of weeks before FDA’s first inspection, and involved a contamination issue: the appearance of particulates in 12-month stability samples of indomethacin, a non-steroidal anti-inflammatory drug. Of the others, two resulted from sterility assurance concerns and one was due to stainless steel particles.

FDA’s May 25, 2011, Form 483 report highlighted a failure to determine why particles had wound up in two contract-manufactured products. The agency said Ben Venue received nine complaints about it from August 2006 to February 2009, and a contract laboratory identified the particles in seven of the cases as stainless steel. Ben Venue neither determined the root cause nor took any corrective or preventive action, the agency said. FDA saw several potential sources that the company should have examined. For example, metal access doors were severely dented and deeply scratched. There were tray racks that appeared to be scratched and rusting, and glass tray carts with rust-like material underneath.

There were numerous observations about Ben Venue’s media fill program. One media fill was deemed acceptable even though the batch size was below the minimum required. FDA worried that people going back and forth through the plastic barrier curtains that set off the aseptic fill Class 100 areas could carry objectionable microorganisms and non-viable particles into the area. And when Ben Venue evaluated air flow patterns, it failed to consider the effect on air flow of the routine manual transfer of filled, partially stoppered vials from the aseptic fill area to the lyophilizer.

A January 2010 sterility failure involved Paenibacillus woosongensisas, the same organism the company had been finding during Class 100 area personnel monitoring over a period of several months.

The company determined that the root cause of an August 2010 sterility failure was the use of gloves that weren’t sterilized, sanitized or cleaned prior to use and that shed fibrous material during use.

FDA noted another sterility failure that occurred in January 2011 in which the company identified the cause as Propionibacterium acnes from isolator gloves that failed integrity testing. But there was no root cause analysis of the source of this anaerobic microorganism.

In all, Ben Venue recovered 1,171 microbial contaminants from classified areas of the site in 2010 and the first quarter of 2011, including 1,047 instances of gram-positive organisms, 108 of gram negative and 16 of mold.

There were some problems with a disinfectant efficacy study the company contracted for in November 2009. For one thing, the contractor didn’t test all types of surfaces in the aseptic processing area, such as rubber bumpers, wheeled carts and castors that appeared to be rust-coated. For another, the stainless steel coupon the contractor tested did not represent the scratched, dented and gouged doors FDA inspectors saw. Plus the organisms used in the study differed from those seen at the site and set forth in compendial guidelines.

FDA also raised a number of additional issues in the May 2011 inspection report, which it posted online in redacted form.

Ben Venue’s second 483 report

FDA's Dec. 2 Form 483 report said Ben Venue’s quality unit lacked authority over its "Project Charter" improvements, which did not appear in the quality system or the corrective and preventive action (CAPA) system.

The plant's weekly "compliance dashboard," which tracks deviations, complaints, change controls, CAPAs and quality protocols is not even part of its quality system, FDA said.

FDA raised a variety of concerns about the qualification of a vial washer. The company qualified it on May 23, 2010, but misplaced the qualification report, an error that did not come to light until March 2011, when people were preparing for the next qualification. Worse, it turned out that the vial washer had not passed the particulate challenge test.

When Ben Venue investigated the case of the misplaced report, it concluded that human error was to blame, but "failed to examine other possible causes such as the lack of an oversight system to alert the validation group that equipment qualifications were past due," FDA said.

The quality unit compounded the error by designating the misplacing of the report as a critical deviation but failing to report it to the quality and operations VPs, and then four days later downgrading it to a major deviation.

Also workers failed to tag out the vial washer while the quality unit was qualifying it.

Another issue that investigators brought to the company's attention was that a thermocouple Ben Venue was using to monitor a room used to incubate media fills was actually located behind a wall.

FDA raised concerns about a number of complaint investigations. In one case, the company investigated a complaint of metal particles by taking wipe samples of production equipment, but did not justify the sample sizes. In a related fill study, it didn’t involve someone knowledgeable in statistics to ensure statistical significance. Also, the company failed to perform all the complaint risk assessments that it should have.

The agency also posted a redacted version of its December 2011 483 report online.

Die cast at Hospira’s Austin, Texas, plant

Hospira was involved in 37 recalls last year, in all but two as the recaller, and in all but one as the manufacturer. Of those recalls, 26 were contamination related, all because of a lack of sterility assurance.

FDA inspections accompanied sterility assurance recalls at three of the four plants where they occurred.

Much of the focus was on Hospira’s Austin, Texas, plant, where 10 sterility assurance recalls occurred March 23, April 6, May 6, Aug. 18 and Nov. 15, 2011.

According to its Form 483 report, FDA found in an April 4-27, 2011, inspection that the plant’s quality unit lacked authority to reject poor procedures or specifications. The plant was not trending bag fabrication rejects by type or creating records of internal meetings about complaint and exception reports.

FDA said the company was not rejecting drug products that failed to meet in-process and post-production quality criteria, instead reworking and re-inspecting the material. Production specialists were culling out defective product without consulting the quality unit.

FDA gave several examples involving products that were the subject of recalls.

After determining that a burr on an imprint die plate had created a pinhole in a polyvinyl chloride bag of 5% Dextrose in Lactated Ringer’s at the “l” in “1000 ml,” causing it to fail an integrity test, production workers went through the inventory, rejecting bags from the batch that displayed the same die position or for no apparent reason.

During the resulting investigation, Hospira received four complaints about five bags from another lot that were leaking in the same way, and therefore at risk of being contaminated. The company expanded the investigation to include that lot, but none prior, and none after the lot that had triggered the inquiry.

Asked why he didn’t query the complaint database about later lots, FDA said the quality investigator responded that it “comes down to investigator style.” In further discussion, he told FDA, “investigations were more of an art,” and said no one kept any records of the investigation’s conversations, emails or phone calls.

When Hospira found the same problem with bags of 0.9% sodium chloride injection, USP, workers culled unfilled bags with the same die position, but allowed a sub-lot of previously filled bags onto the market, regardless of die position, and there was no investigation. “This lot was later recalled due to complaints revealing a number of units on the market were experiencing the characteristic leak,” FDA said. In all, there were eight complaints of 22 incidences, FDA said.

The agency described several cases in the rework record for 5% dextrose and 0.45% sodium chloride injection, USP, where bags were discarded but no investigation resulted. One case involved perimeter seal leaks; two were “due to unqualified person in the area,” the rework record said.

In another case, Hospira production workers discarded bags of 0.9% sodium chloride injection, USP, after one failed an integrity test, without consulting the quality unit or conducting an investigation.

FDA also raised concerns about a lack of training among manufacturing workers, saying the company’s defect identification training program is inadequate.

The agency raised concerns about cleaning and maintenance procedures for the press equipment for making die plates and the dies themselves. FDA observed a material handler using a handheld magnifying glass to visually inspect dies being installed, and running her finger over the face of the imprint plates to detect any defects, even though there were no written procedures for this and no record of the findings.

FDA asserted that the dies were not designed appropriately. The previous owner had qualified the imprint press equipment and dies in 1992. New die plates were required in 2004 when ownership changed. To create them quickly enough, the company used a different material composition without addressing any potential impact on bag integrity.

Also the agency suggested the company was not using the press appropriately. It was routinely shimming die plates by adding thin sheets of metal or tape beneath the plates to ensure legible printing, without making any record of the adjustments, and even as it acknowledged in instructions to workers that “over-shimming dies can cause pin holes in the body of the bag.”

FDA added that a senior mechanic told the agency it is also important not to over-shim the knife/cutter used to create perforations between bags, because “over-shimming can cause seam issues.”

There were also concerns about control and oversight of bag thickness associated with the PVC extrusion process.

Bag sample testing procedures were not always written or appropriate, FDA said, pointing to the company’s “tug test,” which requires employees to grab a bag with one hand and a pair of household pliers with the other to pull on the port housing to make sure it won’t separate from the bag.

How Teva met FDA’s OOS expectations

Given that recalls based on out-of-specification findings doubled last year compared to the annual average over the previous 10 years, it appears that the type of process trending advocated in the recent revision of FDA’s process validation guidance hasn’t yet taken hold.

As the agency’s Brian Hasselbalch explained in an interview, such trending analysis would result in a decrease of out-of-spec recalls such as the ones related to potency, dissolution and other specifications such as impurities/degradants, tablet hardness and tablet weight/thickness.

“If a company were trending properly, they would almost certainly see a problem before they release the batch to the market under the recommendations we gave in Stage III of that guidance,” he said.

Misunderstanding about FDA’s October 2006 out-of-specification guidance appeared to remain an issue, particularly outside the U.S.

A flurry of recalls followed a Sept. 12-16, 2010, inspection of the Teva Pharmaceutical Industries Ltd. facility in Jerusalem and continued throughout the year, totaling 96 by yearend.

A Jan. 31, 2011, warning letter provides some insight into the recalls. During the inspection, FDA found several instances in which the company failed to follow the agency’s OOS guidance.

When one lot failed to meet the specifications for the largest impurity and total impurities, Teva invalidated the test results even though it was unable to confirm a root cause of the failure, FDA said. “Your firm selectively used passing results from a different analysis to approve the lot.”

In its Oct. 7, 2010, written response to the Form 483 report of inspectional observations, Teva said its investigation concluded that the sample had gotten contaminated during processing in the laboratory. “However, you fail to describe how the conclusion was determined, or identify the root cause of the sample contamination,” FDA said. “In addition, you fail to provide corrective actions to prevent a recurrence.”

In another case, the company blamed a weighing instrument for contaminating sample powder found to contain black particles during sample analysis, but didn’t identify the particles, try to see if they came from the manufacturing process or check whether they might have gotten into other lots.

In another case, when a sample reinjection confirmed an OOS result for a finished product assay specification, Teva obtained a barely passing result by preparing a new working solution for the third try. “Your investigation lacks data to support its conclusion that the OOS results were probably related to samples not being properly extracted during the standard solution preparation stage,” FDA said, adding that the investigation should have thoroughly evaluated the manufacturing process and checked for other affected lots.

FDA recommended that Teva review the OOS guidance “for some basic principles regarding conduct of OOS investigations” and emphasized that “we are concerned that your firm has released and distributed finished drug batches to the U.S. market in which the OOS investigations were not scientifically sound. Specifically, we are concerned that laboratory results were invalidated without supporting data and the investigations did not extend to other batches that may have been associated with the failure.”

The agency then requested a list of all finished drug batches shipped to the U.S. within expiry for which there had been an OOS investigation, and requested that Teva “conduct a retrospective review of all opened and closed OOS investigations associated with these U.S. lots.”

FDA requested Teva to provide supporting documentation for each OOS investigation’s evaluations and conclusions, as well as “your corrective actions to prevent a recurrence, where appropriate … and ensure that adulterated drug products have not been released to the U.S. market.”

FDA warned Teva that until it completes all corrections, the agency may withhold approval of any pending applications.

This came at a time when Teva was in a promising position with its abbreviated new drug application for generic Lipitor, with first-to-file competitor Ranbaxy suffering under FDA’s Application Integrity Policy and import alert due to GMP issues at several plants in India Also see "Lipitor Goes Generic, But First-Filer Ranbaxy’s Approval Leaves Plenty Of Questions In Its Wake" - Pink Sheet, 5 December, 2011. ([A#28111212004]).

From the time of the inspection to the warning letter, Teva launched 31 recalls, most of them involving OOS issues. There were failures to meet specifications for weight, color and thickness of tablets, impurities, content uniformity, dissolution and visible particles at various Teva and contract manufacturing facilities in the U.S. and around the world.

On Feb. 23 came 16 more recalls, all from the Jerusalem site, all resulting from a failure to perform laboratory investigations in accordance with FDA’s OOS guidance.

There followed another 43 recalls focusing mainly on OOS-related issues, including 36 before FDA closed out its warning letter.

In the Sept. 9, 20121, closeout letter, the agency said it appeared Teva had addressed the violations and taken appropriate corrective action.

Fifteen of the Teva recalls centered around tablets from a contract manufacturer, Pliva Krakow in Krakow, Poland, that were out of specification for potency, weight or thickness.

These were some of 28 such tablet recalls last year that included 10 overweight-tablet recalls that Aveta Lifesciences trainer Fred Rowley described as part of an ongoing trend related to a need for training among production personnel responsible for running tablet presses ([A#08120328004]).

2011 drug recall analysis by dosage form

This table shows how many drug recalls in 2011 involved which dosage forms, and for each dosage form, how many recalls were for prescription drugs and how many for OTCs, and what problem areas were involved – potency, dissolution, other specifications, contamination, labeling, NDA or manufacturing issues – and how FDA classified the recalls.

Open, download and search a first-ever database from “The Gold Sheet” of last year’s recall information here: ([A#08120328009]).

2011 Drug Recalls

Market Type

Problem Area **

Recall Class

Dose Form *

Rx

OTC

Pot

Dis

Oth

Con

Lab

NDA

Man

I

II

III

O.S.

1307

165

41

34

95

1015

70

125

92

84

1225

163

Top

73

350

10

15

295

8

22

73

1

391

31

Inj

205

7

30

146

10

12

4

185

16

O.L.

111

61

3

2

15

94

20

13

25

3

145

24

Sup

6

6

5

1

5

1

6

6

TP

7

1

6

2

8

Tran

5

3

1

1

6

1

7

Nas

4

3

3

2

1

1

1

6

Ot

2

5

1

1

2

1

2

5

2

Inh

6

2

2

1

1

1

2

3

Op

1

4

1

1

1

2

5

API

2

2

2

MW

2

1

1

2

Totals

1731

598

73

37

166

1565

109

163

216

95

1979

255

* The dosage form categories (and in parentheses, their abbreviations) are: oral solid (os), topical (top), injectable (inj), oral liquid (ol), suppository (sup), toothpaste (tp), transdermal (tran), nasal (nas), otic (ot), inhalation (inh), ophthalmic (op) and active pharmaceutical ingredient (api).

** The problem areas (and in parentheses, their abbreviations) are: potency/content uniformity (pot), dissolution (dis), other product specifications (oth), contamination/sterility assurance (con), labeling/packaging mix-ups (lab), compliance with NDA/monograph requirements (nda), and manufacturing/test methods (man).

2001-2011 Recalls by problem area and dosage form

The following tables list the number of drug recalls for last year, the previous decade and the average over the previous decade by problem area and dose form.

Open, download and search a first-ever database from “The Gold Sheet” of last year’s drug recall information here: ([A#08120328009]).

PROBLEM AREA *

Year

Total

Pot

Dis

Oth

Con

Lab

NDA

Man

2011

2329

95

37

166

1543

109

163

216

2010

849

50

26

257

168

56

177

115

2009

1742

108

14

38

46

52

100

1384

2008

426

61

17

58

43

41

14

192

2007

391

40

17

123

18

152

39

2

2006

384

36

10

59

47

218

6

8

2005

254

32

15

44

47

38

31

47

2004

170

34

12

29

26

35

33

1

2003

181

28

14

26

55

41

12

5

2002

273

55

10

21

120

55

9

3

2001

191

35

18

22

36

28

11

41

2001-2010 ave.

486

48

15

68

61

72

43

180

* The problem areas (and in parentheses, their abbreviations) are: potency/content uniformity (pot); dissolution (dis); other product specifications (oth); contamination/sterility assurance problems (con); labeling/packaging mix-ups (lab); compliance with NDA/monograph requirements (nda); and manufacturing/testing methods (man).

DOSAGE FORM*

Year

Total

OS

Inj

OL

Top

Op

API

Inh

Nas

Sup

Ot

Tran

OHP

2011

2329

1472

205

172

423

5

2

6

7

12

7

8

10

2010

849

374

262

99

48

23

8

6

10

1

5

11

2

2009

1742

1341

89

169

53

23

0

7

3

30

5

14

8

2008

426

310

37

35

13

2

0

4

1

1

4

14

5

2007

391

186

45

54

30

37

0

4

0

2

7

6

20

2006

384

280

35

28

21

8

3

4

1

0

0

3

0

2005

254

119

29

37

27

13

2

6

4

11

1

4

1

2004

170

73

32

18

15

9

2

4

5

4

1

3

2

2003

181

69

61

16

14

8

6

4

1

1

0

1

0

2002

273

138

56

30

28

6

0

8

4

1

2

0

0

2001

191

68

66

14

20

6

5

3

3

1

3

0

2

2001-2010 ave.

486

296

71

50

27

14

3

5

3

5

3

6

4

* The dosage form categories (and in parentheses, their abbreviations) are: oral solid (os), injectable (inj), oral liquid (ol), topical (top), ophthalmic (op), active pharmaceutical ingredient (api), inhalable (inh), nasal (nas), suppository (sup), otic (ot), transdermal (tran), and oral health products (ohp), which include toothpaste, mouth spray, and mouthwash.

Contamination Issues Drove Drug Recalls to Record Levels in 2011

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