Recall: D-0923-2023

Class II - Potentially Harmful

Class IIClassification

2023-06-21Initiated

OngoingStatus

Dr Reddy's Laboratories LimiteFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (N/A). If you take this product, talk to your pharmacist or doctor before stopping it.