NDC 63629-8392
Butalbital, Acetaminophen, and Caffeine 40 mg / 50 mg / 325 mg tablet
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Lannett Company, Inc.'s NDC 0527-1695.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lannett Company, LLC | Seymour, IN, United States | Makes it, packages it and labels it | Problems found, fixed voluntarilyOct 21, 2022 · 9 inspections, 1 with FDA action |
Repackaging site
- Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels it
Recalls
- Sep 28, 2021 · Class III · Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Lots: 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.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Acetaminophen and Butalbital and Caffeine: every company that makes it
- Form
- tablet, oral
- Strength
- 40 mg / 50 mg / 325 mg
- Approval
- ANDA ANDA200243
- On the market since
- Sep 13, 2012
- Package NDCs
63629-8392-063629-8392-163629-8392-263629-8392-363629-8392-463629-8392-563629-8392-663629-8392-763629-8392-863629-8392-9- Official label
- DailyMed (National Library of Medicine), updated Oct 29, 2024
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