🍔 Food 💊 Drugs 🏥 Medical Devices
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 Class II

Reason: CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.

Teva Pharmaceuticals USA 20140324 Terminated
Distributed: Nationwide
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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 Class II

Reason: CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements

Teva Pharmaceuticals USA 20140324 Terminated
Distributed: Nationwide
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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 Class II

Reason: CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements

Teva Pharmaceuticals USA 20140324 Terminated
Distributed: Nationwide
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Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11 Class III

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.

Boehringer Ingelheim Roxane Inc 20140404 Terminated
Distributed: Nationwide
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Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25 Class III

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.

Boehringer Ingelheim Roxane Inc 20140404 Terminated
Distributed: Nationwide
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Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 Class III

Reason: Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Merck & Co Inc 20140113 Terminated
Distributed: Nationwide and Puerto Rico
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Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 Class III

Reason: This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Merck & Co Inc 20140113 Terminated
Distributed: Nationwide and Puerto Rico
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Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 Class III

Reason: This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Merck & Co Inc 20140113 Terminated
Distributed: Nationwide and Puerto Rico
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Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 Class III

Reason: This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Merck & Co Inc 20140113 Terminated
Distributed: Nationwide and Puerto Rico
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Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005351, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. Class II

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

Mangiacotti 20131227 Terminated
Distributed: Nationwide
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