FDA RECALLS CLASSIFIED THROUGH SEPT. 20
SEPT. 20: DRUG-CLASS I
New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: bestherbscoffee@yahoo.com.
Code Information: UPC 557205060083, Exp 5/24/18.
Manufacturer:	Bestherbs Coffee LLC, Arlington, TX
Recalled by:	Bestherbs Coffee two or more of email, fax, letter, press release, telephone or visit on July 17, 2017; classified by FDA on Sept. 12; voluntary recall is ongoing.
Distribution:	Recalling firm distributed to 2 consignees in TX; however recalling firm reported that product is then distributed U.S. nationwide to consumers via individuals or internet; 6,250 packets.
Reason:	Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk. (FDA previously in 2017 found ED drugs and other pharma ingredients in other coffee products available in the US). (Also see "Re-inspection Fees, Spiked Coffee, Recalls: Health And Wellness Industry News" - HBW Insight, 7 August, 2017.)
Recall numbers:	D-1144-2017
DRUG-CLASS I
Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY
Code: a) RO846356 Exp. 8/28/2020; b) RO246852 Exp. 8/28/2020.
Manufacturer:	N/A
Recalled by:	Chiavna Saffron LLC, Huntersville, NC, by press release on July 21, 2017; classified by FDA on Sept. 12; voluntary recall is ongoing.
Distribution:	Nationwide US; 211 bottles; 339 boxes.
Reason:	Marketed without an approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil. (Drugs indicated for erectile dysfunction are the most common pharmaceuticals found in products fraudulently marketed as dietary supplements). (Also see "Regulatory Problems Mount For Supplement Firm Following Recall" - HBW Insight, 1 August, 2017.)
Recall numbers:	D-1145-2017
FOOD-CLASS II
1) Rugby Calcionate Syrup, One Pint (473 mL); 2) Rugby Cerovite Liquid, 8 oz. 236ML; 3) Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, 1 and 2/3 oz., 50 mL; 4) Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL; 5) Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL; 6) Rugby Ferrous Sulfate Liquid One Pint, (473 mL); 7) Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL); 8) Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL); 9) Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL); 10) Major CertaVite Liquid, 8 oz. (236 mL); 11) Major D-Vita Drops, 1 2/3 oz (50 mL); 12) Major Ferrous Drops, 1 2/3 oz (50 mL); 13) Major Poly-Vita Drops, 1 2/3 oz (50 mL); 14) Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL); 15) Major Tri-Vita Drops, 1 2/3 oz (50 mL); 16) Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL); 17) Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL) UPC Number: 0 96295 12862 8.
Code: All unexpired lots for each; 1) UPC Number: 0 05362 77085 1,; 2) UPC Number: 00536-2790-59,; 3) UPC Number: 0 05368 40080 6; 4) UPC Number: 00536-0710-80; 5) UPC Number: 0 05360 16097 0; 6) UPC Number: 0 05360 65085 8; 7) UPC Number: 0 05368 45080 1; 8) UPC Number: 0 05368 53080 0; 9) UPC Number: 0 05368 50180 0; 10) UPC Number: 3 09045 02309 9; 11) UPC Number: 3 09046 27350 9; 12) UPC Number:3 09046 27350 9; 13) UPC Number: 3 09045 09950 6; 14) UPC Number: 3 09045 10050 9; 15) UPC Number: 3 09046 27450 6; 16) UPC Number: 096295128611.
Manufacturer:	The Harvard Drug Group, Livonia, MI
Recalled by:	Harvard Drug Group by press release on Aug. 2, 2017; classified by FDA on Sept. 12; voluntary recall is ongoing.
Distribution:	Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305; 1) 5,771 units; 2) 65,611; 3) 105,628; 4) 27,011; 5) 30,782; 6) 34,280; 7) 113,829; 8) 117,098; 9) 52,897; 10) 61,262; 11) 27,447; 12) 63,005; 13) 27,735; 14) 33,390; 15) 10,074; 16) 3,840; 17) 1,728.
Reason:	The distribution firms Leader Brand, Major Pharmaceuticals and Rugby Laboratories, subsidiaries of Harvard Drug Group, are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. (The Leader, Major and Rugby products are among the supplement and Rx and OTC drug products affected by potentially contaminated water used by contract manufacturer PharmaTech LLC.) (Also see "PharmaTech Recalls Highlight Supplement GMP Diligence For Marketers – CRN" - HBW Insight, 16 August, 2017.)
Recall numbers:	F-3515-2017 throu8gh F-3531-2017
EDITORS’ NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences.

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