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Recall Observatory FDA recall evidence

Drug 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

D-0257-2022

September 28, 2021

Class III

Product summary

Firm
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Event
Event 88847
Status
Ongoing
Classification
Class III
Quantity
574 Bottles
Official record key
drug-enforcement:D-0257-2022

Official wording

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

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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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