D-1066-2019 Class II Terminated
FDA drug recall D-1066-2019 was initiated by Ascend Laboratories LLC on February 22, 2019 and is designated Class II. Reason for recall: Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing. The recall status is terminated (terminated March 18, 2020). Affected quantity: 3,072 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 13, 2019
- Initiation Date
- February 22, 2019
- Termination Date
- March 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,072 bottles
Product Description
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 for Recall
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: 8144652, Exp Jul 2020