Drug product
Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
D-0898-2021
Product summary
- Event
- Event 88736
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1192 bottles
- Official record key
drug-enforcement:D-0898-2021
Official wording
Reason: Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Code information: Lots 2005401, 2005501, 2005601, 2005701, Exp FEB 2023; Lots 2101401, 2101501, Exp FEB-2024
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification