Ascend Laboratories, LLC — Class II: Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx On
Ascend Laboratories, LLC has initiated a Class II recall for Metoprolol Succinate Extended-Release Tablets (25 mg) due to failed dissolution specifications.
This affects Ascend Laboratories, LLC, the manufacturer Alkem Laboratories Ltd., and quality control personnel responsible for testing extended-release oral solids.
A failure in dissolution specifications for an extended-release product suggests potential issues with the controlled-release mechanism or formulation stability. This could lead to sub-therapeutic dosing or unintended release profiles, necessitating a review of manufacturing consistency and release testing procedures for the affected batches.
QA teams should review dissolution testing protocols and stability data for extended-release formulations. Verification of batch records and retention samples for the identified NDC may be necessary to ensure compliance with USP specifications.
Class II. Reason: Failed Dissolution Specifications. Product: Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.. Firm: Ascend Laboratories, LLC (Bedminster NJ United States). Status: Ongoing.
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