D-0898-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 6, 2021
- Initiation Date
- September 21, 2021
- Termination Date
- September 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1192 bottles
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Distribution Pattern
Nationwide
Code Information
Lots 2005401, 2005501, 2005601, 2005701, Exp FEB 2023; Lots 2101401, 2101501, Exp FEB-2024