FDA-Drug2021-12-01Class III

Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Hazard

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

Sold states
Nationwide in the USA
Affected count
119 Bottles
Manufactured in
1919 N Victory Pl, Burbank, CA, United States
Products
Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0256-2022

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