FDA recall D-0898-2021

Product

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

Nationwide

Key facts

Status

Terminated

Initiation date

2021-09-21

Report date

2021-10-06

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-0898-2021