Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 6
Summary
The FDA issued a Class III for Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 6 by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals. Reason: Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label.
Details
Source
Drug Recall
External ID
D-0256-2022
Action Date
2021-12-01
Status
Ongoing
Category
drug
Product Description
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 Info: 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 Affected: 119 Bottles
Reason for Recall
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-28
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 34 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals have FDA actions?
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0256-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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