Reported Mar 13, 2019 · Terminated
Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd.,…
Ascend Laboratories LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ascend Laboratories LLC · 339 Jefferson Rd Ste 101 · Parsippany, NJ · 07054-3707
Is this the product you have?
- Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only
- Manufactured byAlkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05
- Lot codes and dates
Lot #: 8144652Exp Jul 2020
- Amount recalled
- 3,072 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
This product could cause temporary or reversible health problems — stop using it.
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