FDA Drug Class II — Moderate

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

Hazard

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

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Products

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
Brand
Dr Reddy's Laboratories Limited
UPC
Lot: T2100585, T2100586, T2100587, Exp 12/2023

Units Affected

17,548 1000-countbottles

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