Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bo

FDA recall notice · announced December 1, 2021 · Bryant Ranch Prepack, Inc. Dba Brp Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03, barcode 083923153776, e) 90-count bottles, NDC: 71335-1767-04, barcode 083924152889, f) 120-count bottles, NDC: 71335-1767-07, barcode 083927153735. Westminster Pharmaceuticals LLC, Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504 USA

Reason for recall

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

Notes

Distribution: Nationwide in the USA
Lot/code information: a) Lots: 164865, Exp: 2/28/2021; 162113, Exp: 8/31/2022; 160419, Exp: 2/28/2023; 160004, 155752, 154380, 153776, 152889, Exp: 8/31/2022, b) Lots: 157837, 154997, Exp: 8/31/2022, c) Lots: 165687, 160419, 160330, Exp: 2/28/2023; 159973, 159943, 159352, 159345, 158841, 155752, 152347, Exp: 8/31/2022; 152245, 152156, 152197, 151338, 151160, Exp: 7/31/2022, d) Lots: 162641, Exp: 2/28/2023; 154380, 153776, 152889, Exp: 8/31/2022, e)Lots: 158841, 152889, Exp: 8/31/2022, f) Lots: 153776, 153735, 152347, Exp: 8/31/2022
Quantity: 574 Bottles
Status: Ongoing
Products in this recall event:
- 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, (D-0256-2022)
- Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, N (D-0257-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.