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

FDA recall notice · announced July 26, 2023 · Dr Reddy's Laboratories Limited

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot: T2100585, T2100586, T2100587, Exp 12/2023
Quantity: 17,548 1000-countbottles
Status: Ongoing
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.