Class II
Terminated
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
- Company
- Sigmapharm Laboratories Llc
- Recall Initiated
- September 21, 2021
- Posted
- October 6, 2021
- Recall Number
- D-0898-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1192 bottles
- Firm Location
- Bensalem, PA, United States
Reason for Recall
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Distribution
Nationwide
Lot / Code Info
Lots 2005401, 2005501, 2005601, 2005701, Exp FEB 2023; Lots 2101401, 2101501, Exp FEB-2024
More recalls by Sigmapharm Laboratories Llc
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 1...
Sep 1, 2021 · Class II
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