FDA Recall Terminated Historical recordClass II
Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05.
- Reason
- Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
- Published
- March 13, 2019
- Distribution
- Nationwide
