FDAFDA · Food and drugs·Recall number D-0173-2021
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.
Published December 9, 2020 · Recall initiated: November 24, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- TIZANIDINE
- Manufacturer
- Ascend Laboratories LLC
- Distributor
- MI
- Lot
- Lot #19143017, Exp. 05/31/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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