FDA recall D-0256-2022

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals · Class III · drug

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2021-09-28
Report date: 2021-12-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Burbank, CA, United States

Primary source

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