FDA Recall Terminated Historical recordClass III
Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
- Reason
- Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
- Published
- March 2, 2022
- Distribution
- Nationwide
