Class I - Dangerous
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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Prescription Drugs
💊 Drugs • 12,141 recalls
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
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
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.
Boehringer Ingelheim Roxane
Class I - Dangerous
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
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
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
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
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
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
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
Sandoz Incorporated
Class I - Dangerous
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
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
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
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
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC
Mckesson Packaging Services
Class I - Dangerous
Failed Dissolution Specification; at the 12 month time interval.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
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
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
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
Daiichi Sankyo Pharma Development
Class I - Dangerous
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class I - Dangerous
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01
Shamrock Medical Solutions Group
Class I - Dangerous
Labeling: Label Mix up; product labeled did not indicated Extended Release
Class I - Dangerous
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.