Drug product
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.
D-1066-2019
Product summary
- Event
- Event 82223
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,072 bottles
- Official record key
drug-enforcement:D-1066-2019
Official wording
Reason: Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Code information: Lot #: 8144652, Exp Jul 2020
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out-of-Specification