FDA-Drug2021-09-01Class II
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
SigmaPharm Laboratories LLC
Hazard
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Sold states
Disttibuted Nationwide in the USA.
Affected count
1,993 bottles
Manufactured in
3375 Progress Dr, N/A, Bensalem, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0766-2021Don't want to check this manually?
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