Dr. Reddy’s Laboratories Ltd. today announced that it is voluntarily recalling six (6) 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.
- Risk Statement: Reduced efficacy of the product would result in elevated Phenylalaninemia (Phe) levels in patients. Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to this recall to date.
Source: FDA
