Thursday, May 22, 2014

FDA Enforcement Report May 21, 2014 --Drugs

Drugs REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original. All lots Class I Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol. Pain Free By Nature
Drugs GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05 TE36018, Exp. 06/15 Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Teva Pharmaceuticals USA
Drugs INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01 TE32134, Exp. 02/15 Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Teva Pharmaceuticals USA
Drugs INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 TE38139, Exp. 08/16, TE39022, Exp. 09/16, Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. Teva Pharmaceuticals USA
Drugs METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01 TE36053A,TE36063A, Exp. 06/16 Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Teva Pharmaceuticals USA
Drugs Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA Aspirin was packed into Ibuprofen boxes (Item Number FAE-7014) coded: B11340515, B11840515, B12040615, B12540615, B12640615, B12740615, C10340615 and B11040516. Class II First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets). First Aid Only Inc
Drugs PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10. Lot #: A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16) Class III Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. Konsyl Pharmaceuticals Inc
Drugs Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-Seine Cedex, barcode *3421357* Lot #: F040, Exp 08/16 Class II Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote. Flawless Beauty LLC
Drugs Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576 Lot #: UB302, Exp 05/12/15 Class II Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote. Flawless Beauty LLC
Drugs Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manufactured by: Shandong Luye Pharmaceutical Co. Ltd, Yantai Shandong, PRC la Luye Pharma Subsidiary, UPC 6920425209014 Lot #: 201302275, Exp 01/20/15; 201308384, Exp 10/19/2015 Class II Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote. Flawless Beauty LLC
Drugs Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count 5 mL vitamin C (ascorbic acid) solution diluent ampoules, and 30-count Advanced Glutathione Boosters capsules per box, Relumins Labs, 183 Locust Avenue, West Long Branch, NJ 07764, UPC 700175760302 Lot #: 130616, Exp 06/16 Class II Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims. Flawless Beauty LLC
Drugs Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533 Lot #: 556273, Exp 9/25/16; 556219, Exp 8/2/16, or any other lot distributed by Flawless Beauty. Class II Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease. Flawless Beauty LLC
Drugs Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219 Lot #: 16U394, Exp 04/16; 16U421, Exp 08/16; 16U423, Exp 09/16 Class II Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection. Flawless
















 

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