Recalls / Class II
Class IID-0173-2021
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.
- Brand name
- Tizanidine
- Generic name
- Tizanidine
- Active ingredient
- Tizanidine Hydrochloride
- Route
- Oral
- NDCs
- 67877-613, 67877-614
- FDA application
- ANDA211798
- Affected lot / code info
- Lot #19143017, Exp. 05/31/2021
Why it was recalled
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Recalling firm
- Firm
- Ascend Laboratories LLC
- Manufacturer
- Ascend Laboratories, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 1200 bottles
- Distribution pattern
- MI
Timeline
- Recall initiated
- 2020-11-24
- FDA classified
- 2020-12-22
- Posted by FDA
- 2020-12-09
- Terminated
- 2023-04-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0173-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.