Class II · Moderate risk Completed
Tizanidine Tablets
Reason Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Tizanidine Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
What was recalled
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
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0173-2021
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Tizanidine recalls
See all
Class II · Moderate risk Ongoing
Tizanidine Hydrochloride Tablet 4mg
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
Tizanidine Tablets
Reason Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Class II · Moderate risk Ongoing
Tizanidine Tablets USP
Reason Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Class II · Moderate risk Terminated
Tizanidine HCl Tablets
Reason Failed Tablet/Capsule Specification: Some tablets are shaved
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