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Recall Observatory FDA recall evidence

Drug product

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.

D-0892-2023

June 23, 2023

Class II

Product summary

Firm
Amerisource Health Services LLC
Event
Event 92607
Status
Terminated
Classification
Class II
Quantity
4,971 cartons
Official record key
drug-enforcement:D-0892-2023

Official wording

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.

Code information: Lot 1004835, Exp 7/31/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification