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Recall Observatory FDA recall evidence

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.

D-0256-2022

September 28, 2021

Class III

Product summary

Firm
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Event
Event 88847
Status
Ongoing
Classification
Class III
Quantity
119 Bottles
Official record key
drug-enforcement:D-0256-2022

Official wording

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

Code information: a) Lots: 152838, 152156, 152151, 151708, 151693, 151375, 151131, 151114, Exp: 7/31/2022, b) Lots: 152245, 151822, 151708, 151160, 151131, Exp: 7/31/2022, c) Lot #: 152614, Exp: 7/31/2022.

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