Drug product
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
D-0923-2023
Product summary
- Event
- Event 92564
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17,548 1000-countbottles
- Official record key
drug-enforcement:D-0923-2023
Official wording
Reason: Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Code information: Lot: T2100585, T2100586, T2100587, Exp 12/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification