FDA Recall D-0256-2022

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals · Burbank, CA

Class III Ongoing 1689 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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.

Lot / code: 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.

Quantity: 119 Bottles

Reason for recall

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

Recall record

Recall number: D-0256-2022
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2021-09-28
Classified by FDA Center: 2021-11-23
FDA published: 2021-12-01
Recalling firm: Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Firm location: Burbank, CA

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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