FDA-Drug2021-10-06Class II
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
SigmaPharm Laboratories LLC
Hazard
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Sold states
Nationwide
Affected count
1192 bottles
Manufactured in
3375 Progress Dr, N/A, Bensalem, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0898-2021Don't want to check this manually?
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