Class II · Moderate risk
PredniSONE Tablets USP
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Paricalcitol Capsules
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Class III · Low risk
Clonazepam Tablets
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Class III · Low risk
Clonazepam Tablets
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
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 I · High risk
Lidocaine HCL/ Sodium Bicarb
Non-Sterility: failed sterility test result.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
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
Class II · Moderate risk
Trimix Injectable 30 mg/3 mg/60 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Injectable 30 mg/3 mg/100 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Injectable 30 mg/1 mg/25 mcg/mL
Lack of Assurance of Sterility