FDARecalled Jun 17, 2026 · #D-0597-2026
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 ...
Hazard
Class II — temporary health risk
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Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis Classification: Class II Distribution: Nationwide in the USA
Product details
- 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
- Type
- Drugs
- Manufacturer
- Ascend Laboratories, LLC
- Model numbers
- 25141635
- UPCs
- —