Class I - Dangerous
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Class I - Dangerous
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I - Dangerous
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94
The Harvard Drug Group LLC
Class I - Dangerous
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I - Dangerous
Presence of Particulate Matter: Silicone
Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9
Omega & Delta Co.
Class I - Dangerous
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4
Omega & Delta Co.
Class I - Dangerous
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class I - Dangerous
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.
Family Medical Supply
Class I - Dangerous
cGMP Deviations
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01
Zydus Pharmaceuticals (USA)
Class I - Dangerous
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Presence of Particulate Matter: identified as glass.
Class I - Dangerous
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.
Zydus Pharmaceuticals (USA)
Class I - Dangerous
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Amneal Pharmaceuticals of New York
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Presence of Particulate Matter: identified as glass.
Class I - Dangerous
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Class I - Dangerous
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.