Qvents

Qvents

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Warning letters, 483s, Recalls, Import Alerts, Audit observations

Dr Reddys (DRL) initiated recall of one batch of Tizanidine 4mg tablets in US in January 2024. The recall is due to presence of foreign tablet – Tizanidine 2mg tablets in the bottle of Tizanidine 4mg tablets. Tizanidine is a short-acting muscle relaxer, indicated for treatment of muscle spasticity.

Recall Enforcement Report

As per DRL product label both Tizanidine 4mg and 2 mg tablets are white to off white, oval, flat, beveled edged tablets; with debossing “R180” and quadrisecting score in 4mg tablets & debossing “R179” and bisecting score on 2mg tablets. The recalled Tizanidine Tablets 4mg are manufactured at  DRL’s  Srikakulam facility in India.

In a similar incident Dr.Reddy’s had recalled Tacrolimus 1mg Capsules for finding of Tacrolimus 0.5mg Capsule in a bottle in December 2023. This was manufactured at DRL’s Bachupally facility in India.

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