Drug product
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
D-0766-2021
Product summary
- Event
- Event 88474
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,993 bottles
- Official record key
drug-enforcement:D-0766-2021
Official wording
Reason: Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Code information: Lot Numbers: 1813001, 1813101, 1813201, EXP. May 2023; 1822601, 1822701, EXP Nov 2023; 1905701, 1905801, 1906501, 1906601, 1906701, EXP May 2024
Distribution pattern: Disttibuted Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of Specification