FDAFDA · Food and drugs·Recall number D-0892-2023
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.
Published July 12, 2023 · Recall initiated: June 23, 2023
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: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TIZANIDINE
- Manufacturer
- Amerisource Health Services LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot 1004835, Exp 7/31/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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