Drug product
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).
D-0640-2022
Product summary
- Event
- Event 89626
- Status
- Terminated
- Classification
- Class III
- Quantity
- 340 packets
- Official record key
drug-enforcement:D-0640-2022
Official wording
Reason: Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Code information: T2100891, Exp. 02/28/2024
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Subpotent