FDA recall D-0766-2021

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

Reason for recall

Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.

Distribution

Disttibuted Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2021-08-13

Report date

2021-09-01

Termination date

2022-09-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bensalem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0766-2021