Drug 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.
D-0486-2024
Product summary
- Event
- Event 94369
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 2402 cartons
- Official record key
drug-enforcement:D-0486-2024
Official wording
Reason: Sub-potent Drug; powder discoloration associated with decreased potency
Code information: Lot # T2200352, Exp. 12/31/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Sub-potent Drug; powder discoloration associated with decreased potency