Class II · Moderate risk Terminated
Salsalate Tablets
Reason CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Salsalate Tablets
Reason CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk Terminated
Phenazopyridine Hydrochloride Tablets
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
Phenazopyridine Hydrochloride Tablets
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
Indiomin MB URINARY ANTISEPTIC
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
AZUPHEN MB URINARY ANTISEPTIC Capsules
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
UROPHEN MB URINARY ANTISEPTIC Tablets
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
URAMIT MB URINARY ANTISEPTIC Capsules
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
Urolet Mb Urinary Antiseptic
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
Hyolev MB URINARY ANTISEPTIC Tablets
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
Sodium Chloride Ophthalmic Solution
Reason Subpotent Drug: concentration of product is less than labeled amount.
Class II · Moderate risk Terminated
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles
Reason 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.
Class II · Moderate risk Terminated
Succinylcholine Chloride
Reason Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
Class II · Moderate risk Terminated
DIPYRIDAMOLE Tablets USP
Reason 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.
Class II · Moderate risk Terminated
Persantine
Reason 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.
Class II · Moderate risk Terminated
Travoprost Ophthalmic Solution USP
Reason Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Class II · Moderate risk Terminated
Phenobarbital Tablets
Reason Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Class II · Moderate risk Terminated
PredniSONE Tablets USP
Reason Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Class II · Moderate risk Terminated
USCG Boat Response Kit - Product Code 80-0353
Reason Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk Terminated
Aid Backpack Kit - Product Code 85-0917
Reason Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk Terminated
Mini Resupply Trauma Kit - Product Code 85-0835
Reason Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk Terminated
Amphibious Trauma Kit - Product Code 85-0639
Reason Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk Terminated
K-9 Trauma Field Kit - Product Code 80-0211
Reason Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk Terminated
Advance Trauma Kit - Product Code 85-0742
Reason Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk Terminated
Range Trauma Kit - Product Code 85-1274
Reason Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.