Drug 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
D-0597-2026
Product summary
- Event
- Event 99129
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 360 30-count bottles
- Official record key
drug-enforcement:D-0597-2026
Official wording
Reason: Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Code information: Lot# 25141635, Exp 4/30/2028
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out-of-specification