FDA Recall
Terminated
Historical recordClass III
Cataflam (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.
by Novartis Pharmaceuticals Corp.
- Reason
- Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
- Published
- August 13, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
by Janssen Pharmaceuticals, Inc.
- Reason
- Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
- Published
- August 13, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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.
by Wockhardt Usa Inc.
- Reason
- Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
- Published
- August 13, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
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.
by Alexion Pharmaceuticals, Inc.
- Reason
- Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
- Published
- August 13, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Caraco Pharmaceutical Laboratories, Ltd.
- 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.
- Published
- August 13, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Caraco Pharmaceutical Laboratories, Ltd.
- 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.
- Published
- August 13, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
by Sandoz Incorporated
- Reason
- Presence of Foreign Substance; tablets may contain stainless steel metal particulates
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tribenzor 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
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Benicar 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
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Benicar 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
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Azor 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
by Daiichi Sankyo Pharma Development
- Reason
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan 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
by Jubilant Cadista Pharmaceuticals Inc.
- Reason
- Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
triple 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
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Pre served and fragrance-free, Manufactured by: Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120, NDC 51552-1285-8,
by Fagron, Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.
by Fagron, Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6.
by Fagron, Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
- Published
- August 6, 2014
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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