Ascend Laboratories, LLC — Class II: Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only,
Ascend Laboratories, LLC has initiated a Class II recall for Minocycline Hydrochloride Extended-Release Tablets (115 mg) due to an out-of-specification dissolution test result observed during the ninth month of analysis.
This affects Ascend Laboratories, LLC, the manufacturer Alkem Laboratories Ltd., and entities involved in the distribution and quality oversight of generic extended-release tetracycline-class antibiotics.
A failure in dissolution specifications for an extended-release product suggests potential inconsistencies in the drug release profile over its shelf life, which may impact therapeutic efficacy or safety. The occurrence of an OOS result at the nine-month mark indicates that stability-related degradation or physical changes in the matrix may be bypassing initial release testing, necessitating a review of long-term stability data and manufacturing controls.
QA/QC departments should review current stability testing protocols and dissolution profiles for extended-release products. Regulatory teams should ensure that any OOS results observed during long-term stability testing are promptly investigated and reported via the appropriate recall or field alert mechanisms.
Class II. Reason: Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis. Product: Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30. Firm: Ascend Laboratories, LLC (Bedminster NJ United States). Status: Ongoing.
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