Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Consumers and healthcare providers should stop using this product immediately. Contact Apotex Corp. or your healthcare provider for guidance. Notification method: Letter
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.. Generic: KETOROLAC TROMETHAMINE; Brand: KETOROLAC TROMETHAMINE. Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns. Classification: Class II. Quantity: 493,468 bottles. Distribution: Nationwide in the US
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Glenmark Pharmaceuticals Inc. recalled 13,824 tubes of Azelaic Acid Gel on September 17, 2025. The recall stems from market complaints regarding a gritty texture. Consumers should stop using the product immediately and contact their healthcare provider.