Ascend Laboratories, LLC: Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem…
| Source | FDA · Drugs |
|---|---|
| Date | 2026-06-17 |
| 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 |
| Reason / hazard | Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis |
| Classification | Class II |
| Official notice | — |
| Record ID | fda-drug:D-0597-2026 |