Recalls / Class II
Class IID-1066-2019
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.
- Brand name
- Tamsulosin Hydrochloride
- Generic name
- Tamsulosin Hydrochloride
- Active ingredient
- Tamsulosin Hydrochloride
- Route
- Oral
- NDC
- 67877-450
- FDA application
- ANDA207405
- Affected lot / code info
- Lot #: 8144652, Exp Jul 2020
Why it was recalled
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Recalling firm
- Firm
- Ascend Laboratories LLC
- Manufacturer
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 3,072 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2019-02-22
- FDA classified
- 2019-03-29
- Posted by FDA
- 2019-03-13
- Terminated
- 2020-03-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1066-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.