Dr. Reddy’s issues voluntary nationwide recall of Sapropterin Dihydrochloride Powder for Oral Solution

24 Apr 2024 Evaluate

Dr. Reddy's Laboratories is voluntarily recalling six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints.

Dr. Reddy’s Laboratories Inc. is notifying its distributors and customers by recall notification letters and is arranging for returns of all recalled products. Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should contact their physician before stopping use of the product. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should return it to their place of purchase. 

Dr. Reddy's Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.


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