Tamsulosin Hydrochloride Capsules recall: Failed Dissolution
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.
Why was Tamsulosin Hydrochloride Capsules recalled?
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 8144652, Exp Jul 2020
- 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.
- Recalling firm
- Ascend Laboratories LLC
- Quantity
- 3,072 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Recall date
- March 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)