Recalls / Class II
Class IID-0892-2023
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.
- Brand name
- Tizanidine
- Generic name
- Tizanidine
- Active ingredient
- Tizanidine Hydrochloride
- Route
- Oral
- NDCs
- 68084-645, 68084-775
- FDA application
- ANDA076286
- Affected lot / code info
- Lot 1004835, Exp 7/31/2023
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.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 4,971 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-06-23
- FDA classified
- 2023-06-30
- Posted by FDA
- 2023-07-12
- Terminated
- 2024-09-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0892-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.