
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.
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.
Leave a Comment
You must be logged in to post a comment.