Reported Jul 12, 2023 · Terminated
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and…
Amerisource Health Services LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amerisource Health Services LLC · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188
Is this the product you have?
- 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 PackagingColumbusOhio 43217NDC 68084-645-01 (carton)barcode (01) 003 68084 645 11 2
- Lot codes and dates
Lot 1004835Exp 7/31/2023
- Amount recalled
- 4,971 cartons
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
This product could cause temporary or reversible health problems — stop using it.
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