FDA Drug Recalls
966 recalls · Class II, newest first
Oct 19, 2016
Class II · Moderate risk
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
Oct 12, 2016
Class II · Moderate risk
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
Oct 6, 2016
Class II · Moderate risk
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Oct 6, 2016
Class II · Moderate risk
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Oct 5, 2016
Class II · Moderate risk
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Oct 3, 2016
Class II · Moderate risk
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Oct 3, 2016
Class II · Moderate risk
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Sep 27, 2016
Class II · Moderate risk
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Sep 27, 2016
Class II · Moderate risk
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Sep 27, 2016
Class II · Moderate risk
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Sep 27, 2016
Class II · Moderate risk
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Sep 27, 2016
Class II · Moderate risk
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Sep 27, 2016
Class II · Moderate risk
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Sep 27, 2016
Class II · Moderate risk
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Sep 27, 2016
Class II · Moderate risk
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Sep 27, 2016
Class II · Moderate risk
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Sep 21, 2016
Class II · Moderate risk
Lack of Assurance of Sterility
Sep 21, 2016
Class II · Moderate risk
Lack of Assurance of Sterility
Sep 21, 2016
Class II · Moderate risk
Lack of Assurance of Sterility
Sep 21, 2016
Class II · Moderate risk
Lack of Assurance of Sterility
Sep 21, 2016
Class II · Moderate risk
Lack of Assurance of Sterility
Sep 21, 2016
Class II · Moderate risk
Lack of Assurance of Sterility
Sep 21, 2016
Class II · Moderate risk
Lack of Assurance of Sterility
Sep 21, 2016
Class II · Moderate risk
Lack of Assurance of Sterility
Sep 21, 2016
Class II · Moderate risk
Lack of Assurance of Sterility