Class II
Terminated
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.
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- February 22, 2019
- Posted
- March 13, 2019
- Recall Number
- D-1066-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,072 bottles
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Distribution
Nationwide in the USA and Puerto Rico.
Lot / Code Info
Lot #: 8144652, Exp Jul 2020
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