Failed Dissolution Specifications
Failed Dissolution Specifications
Consumers and healthcare providers should stop using this product immediately. Contact Ascend Laboratories, LLC or your healthcare provider for guidance. Notification method: Letter
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.. Generic: ATORVASTATIN CALCIUM; Brand: ATORVASTATIN CALCIUM. Reason: Failed Dissolution Specifications. Classification: Class II. Quantity: 141,984 bottles. Distribution: U.S. Nationwide
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Bristol-Myers Squibb recalled 12,778 vials of Opdualag injection on October 21, 2025. The recall stems from a lack of assurance of sterility. The affected products were distributed nationwide in the United States.
Major Pharmaceuticals recalled Gabapentin Capsules, USP, 100 mg, on October 10, 2025, due to failed impurities specifications. The recall affects several lot numbers distributed nationwide. Consumers must stop using the affected capsules immediately.
Lannett Company, Inc. recalled 46,848 bottles of Niacin Extended-release Tablets on October 10, 2025. The recall follows reports of failed dissolution specifications, which could affect medication effectiveness. Consumers should stop using the product immediately and consult healthcare providers for guidance.