Class II
Terminated
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
- Company
- Sigmapharm Laboratories Llc
- Recall Initiated
- August 13, 2021
- Posted
- September 1, 2021
- Recall Number
- D-0766-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,993 bottles
- Firm Location
- Bensalem, PA, United States
Reason for Recall
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Distribution
Disttibuted Nationwide in the USA.
Lot / Code Info
Lot Numbers: 1813001, 1813101, 1813201, EXP. May 2023; 1822601, 1822701, EXP Nov 2023; 1905701, 1905801, 1906501, 1906601, 1906701, EXP May 2024
More recalls by Sigmapharm Laboratories Llc
Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps...
Oct 6, 2021 · Class II
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