Class II · Moderate risk Ongoing
Desipramine Hydrochloride Tablets
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Desipramine Hydrochloride Tablets
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk Ongoing
Desipramine Hydrochloride Tablets
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk Ongoing
Desipramine Hydrochloride Tablets
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk Ongoing
Tavaborole Topical solution 5%
Reason Discoloration
Class II · Moderate risk Ongoing
Testo-100 Ciii
Reason Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Class II · Moderate risk Ongoing
Zicam" Medicated Fruit Drops Elderberry Flavor
Reason Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Injection
Reason Presence of Particulate Matter: Particulate matter identified as glass
Class II · Moderate risk Ongoing
Medline
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Doxycycline Hyclate Tablets
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class II · Moderate risk Ongoing
Afco
Reason cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Class II · Moderate risk Ongoing
Wyandotte
Reason cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Class II · Moderate risk Ongoing
Succinylcholine Chloride Injection
Reason Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk Ongoing
Aloe Up Sport Performance Sunscreen Lotion SPF 30
Reason cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Class II · Moderate risk Ongoing
Entecavir Tablets
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk Ongoing
Entecavir Tablets
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk Ongoing
Fentanyl citrate
Reason CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Class II · Moderate risk Ongoing
Sting Relief Swabs
Reason Product Mix-up
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Azelaic Acid Gel
Reason CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II · Moderate risk Ongoing
Phenylephrine HCI
Reason CGMP Deviations
Class I · High risk Ongoing
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Reason Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.