Press Release24 Apr 2024, 02:01 am
Dr. Reddy's Laboratories Voluntarily Recalls Batch of Sapropterin Dihydrochloride Powder due to Sub-potency
AI Summary
Dr. Reddy's Laboratories Ltd. has announced a voluntary recall of six batches of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg due to sub-potency. This decision follows the discovery of powder discoloration during an accelerated stability test and customer complaints. The issue, if not addressed, could result in reduced product efficacy and elevated Phenylalanine levels, leading to potential neurocognitive deficits in infants and children, as well as developmental delays, seizures, and negative effects during pregnancy. The recalled batches were distributed nationwide.
Key Highlights
- Dr. Reddy's recalls six batches of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg
- Sub-potency issue caused by powder discoloration discovered during accelerated stability test
- Customer complaints triggered the recall
- Reduced potency might result in elevated Phenylalanine levels
- Elevated Phe levels could cause neurocognitive deficits, developmental delays, seizures, and potentially negative effects during pregnancy