D-0766-2021 Class II Terminated
FDA drug recall D-0766-2021 was initiated by SigmaPharm Laboratories LLC on August 13, 2021 and is designated Class II. Reason for recall: Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing. The recall status is terminated (terminated September 26, 2022). Affected quantity: 1,993 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 1, 2021
- Initiation Date
- August 13, 2021
- Termination Date
- September 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,993 bottles
Product Description
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
Reason for Recall
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Distribution Pattern
Disttibuted Nationwide in the USA.
Code Information
Lot Numbers: 1813001, 1813101, 1813201, EXP. May 2023; 1822601, 1822701, EXP Nov 2023; 1905701, 1905801, 1906501, 1906601, 1906701, EXP May 2024