Drug product
Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153
D-1191-2018
Product summary
- Event
- Event 80953
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8376 units
- Official record key
drug-enforcement:D-1191-2018
Official wording
Reason: Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Code information: Lot #: T800304, Exp. 03/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets