🍔 Food 💊 Drugs 🏥 Medical Devices
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11 Class II

Reason: Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample

Janssen Pharmaceuticals, Inc. 20130911 Terminated
Distributed: Nationwide
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buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07. Class III

Reason: Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.

Wockhardt Usa Inc. 20140714 Terminated
Distributed: Nationwide
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Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6. Class I

Reason: Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.

Alexion Pharmaceuticals, Inc. 20140602 Terminated
Distributed: Nationwide and Puerto Rico
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Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. Class II

Reason: CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

Caraco Pharmaceutical Laboratories, Ltd. 20140626 Terminated
Distributed: Nationwide and Puerto Rico
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Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. Class II

Reason: CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

Caraco Pharmaceutical Laboratories, Ltd. 20140626 Terminated
Distributed: Nationwide and Puerto Rico
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Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10 Class II

Reason: Presence of Foreign Substance; tablets may contain stainless steel metal particulates

Sandoz Incorporated 20140725 Terminated
Distributed: Nationwide
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Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90 Class II

Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.

Daiichi Sankyo Pharma Development 20140712 Terminated
Distributed: Nationwide
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Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30 Class II

Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.

Daiichi Sankyo Pharma Development 20140712 Terminated
Distributed: Nationwide
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Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90 Class II

Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.

Daiichi Sankyo Pharma Development 20140712 Terminated
Distributed: Nationwide
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Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18 Class II

Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Daiichi Sankyo Pharma Development 20140712 Terminated
Distributed: Nationwide
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