Tizanidine Tablets recall: Failed Dissolution
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.
Why was Tizanidine Tablets recalled?
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
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 #19143017, Exp. 05/31/2021
- Product
- Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.
- Recalling firm
- Ascend Laboratories LLC
- Quantity
- 1200 bottles
- Distribution
- MI
- Recall date
- December 9, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)