Minocycline Hydrochloride Extended-Release Tablets recall: Failed Dissolution
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
Why was Minocycline Hydrochloride Extended-Release Tablets recalled?
Failed Dissolution Specifications: low out of specification results for dissolution 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 #: 19140414, Exp 12/2020
- Product
- Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
- Recalling firm
- Ascend Laboratories LLC
- Quantity
- 4728 bottles
- Distribution
- Nationwide in the USA
- Recall date
- February 12, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)