Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2014-08-13FDA-DrugMedical Supply Liquidators LlcClass IIB Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
- 2014-08-13FDA-DrugMedical Supply Liquidators LlcClass IIVitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
- 2014-08-13FDA-DrugMedical Supply Liquidators LlcClass IISuper MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
- 2014-08-13FDA-DrugMedical Supply Liquidators LlcClass IIMIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
- 2014-08-13FDA-DrugMedical Supply Liquidators LlcClass IIVitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
- 2014-08-13FDA-DrugMedical Supply Liquidators LlcClass IIVitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us.
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
- 2014-08-13FDA-DrugMedical Supply Liquidators LlcClass IIVitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
- 2014-08-13FDA-DrugMedical Supply Liquidators LlcClass IIBCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
- 2014-08-13FDA-DrugMedical Supply Liquidators LlcClass IIVitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
- 2014-08-13FDA-DrugMedical Supply Liquidators LlcClass IIVitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
- 2014-08-13FDA-DrugHLI dba Humphreyline IncClass IIAlcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson Community College Nursing.
Microbial Contamination of Non-Sterile Product
- 2014-08-13FDA-DrugSST CorporationClass IITetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
- 2014-08-13FDA-DrugNovartis Pharmaceuticals Corp.Class IIICataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
- 2014-08-13FDA-DrugMckesson Packaging ServicesClass IIAlprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
- 2014-08-13FDA-DrugJanssen Pharmaceuticals, Inc.Class IIRisperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
- 2014-08-13FDA-DrugWockhardt Usa Inc.Class IIIbuPROPion 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.
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
- 2014-08-13FDA-DrugAlexion Pharmaceuticals, Inc.Class ISoliris (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.
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
- 2014-08-13FDA-DrugCaraco Pharmaceutical Laboratories, Ltd.Class IICephalexin 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.
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
- 2014-08-13FDA-DrugCaraco Pharmaceutical Laboratories, Ltd.Class IICephalexin 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.
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
- 2014-08-06FDA-DrugSandoz IncorporatedClass IIAlprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
- 2014-08-06FDA-DrugDaiichi Sankyo Pharma DevelopmentClass IIBenicar 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
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
- 2014-08-06FDA-DrugDaiichi Sankyo Pharma DevelopmentClass IIBenicar 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
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
- 2014-08-06FDA-DrugDaiichi Sankyo Pharma DevelopmentClass IIBenicar 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
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
- 2014-08-06FDA-DrugDaiichi Sankyo Pharma DevelopmentClass IIWelchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- 2014-08-06FDA-DrugDaiichi Sankyo Pharma DevelopmentClass IITribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- 2014-08-06FDA-DrugDaiichi Sankyo Pharma DevelopmentClass IIBenicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- 2014-08-06FDA-DrugDaiichi Sankyo Pharma DevelopmentClass IIBenicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- 2014-08-06FDA-DrugDaiichi Sankyo Pharma DevelopmentClass IIAzor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- 2014-08-06FDA-DrugJubilant Cadista Pharmaceuticals Inc.Class IILosartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
- 2014-08-06FDA-DrugTeva Pharmaceuticals USAClass IItriple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
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