Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratorie...
FDA Recall #D-0923-2023 — Class II — June 21, 2023
Product Description
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.
Recalling Firm
Dr Reddy's Laboratories Limited — Ranasthalam Mandal, Srikakulam, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
17,548 1000-countbottles
Distribution
Nationwide in the USA
Code Information
Lot: T2100585, T2100586, T2100587, Exp 12/2023
Status
Ongoing
Voluntary / Mandated
N/A