Product: Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
Reason for recall: Sub-potent Drug; powder discoloration associated with decreased potency
Recall initiated: 20240408
Status: Ongoing
Classification: Class I
Recall type: Voluntary: Firm initiated