Class II · Moderate risk Ongoing
Doctor. D. Schwab Mineral Sunscreen SPF 50
Reason CGMP Deviations
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
R.E.C.K.
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
Hadlima
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Ongoing
Niacin Extended-release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class II · Moderate risk Ongoing
Taoscare Motion Sickness Patches 36-count box
Reason Marketed Without an Approved NDA/ANDA
Class II · Moderate risk Ongoing
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %
Reason Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Class II · Moderate risk Ongoing
Sucralfate Tablets
Reason CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II · Moderate risk Ongoing
Fasenra
Reason Lack of Assurance of Sterility:
Class II · Moderate risk Ongoing
Prazosin Hydrochloride
Reason CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II · Moderate risk Ongoing
Prazosin Hydrochloride
Reason CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II · Moderate risk Ongoing
Prazosin Hydrochloride
Reason CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II · Moderate risk Ongoing
Carbidopa
Reason Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
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
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