Class II · Moderate risk
URAMIT MB URINARY ANTISEPTIC Capsules
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Urolet Mb Urinary Antiseptic
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Hyolev MB URINARY ANTISEPTIC Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Sodium Chloride Ophthalmic Solution
Subpotent Drug: concentration of product is less than labeled amount.
Class II · Moderate risk
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles
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
Succinylcholine Chloride
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
DIPYRIDAMOLE Tablets USP
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
Persantine
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
Travoprost Ophthalmic Solution USP
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Class II · Moderate risk
Phenobarbital Tablets
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Class II · Moderate risk
PredniSONE Tablets USP
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Class II · Moderate risk
USCG Boat Response Kit - Product Code 80-0353
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Aid Backpack Kit - Product Code 85-0917
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Mini Resupply Trauma Kit - Product Code 85-0835
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Amphibious Trauma Kit - Product Code 85-0639
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
K-9 Trauma Field Kit - Product Code 80-0211
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Advance Trauma Kit - Product Code 85-0742
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Range Trauma Kit - Product Code 85-1274
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Range Trauma Kit ORG - Product Code 80-0213
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Range Trauma Kit Hardcase - Product Code 85-0889
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Testosterone Cypionate in Sesame Oil Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate in Grapeseed Oil Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin D3 in Sesame Oil Injectable 50
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin D3 in Sesame Oil Injectable 100
Lack of Assurance of Sterility
Class II · Moderate risk
Tri-Test 200
Lack of Assurance of Sterility