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.
Reported: March 13, 2019 Initiated: February 22, 2019 #D-1066-2019
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.
Details
- Recalling Firm
- Ascend Laboratories LLC
- Units Affected
- 3,072 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ascend Laboratories LLC. Units affected: 3,072 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 13, 2019. Severity: Moderate. Recall number: D-1066-2019.
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