NDC 71335-1158
Primidone 50 mg tablet
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Lannett Company, Inc.'s NDC 0527-1301.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lannett Company, LLC | Seymour, IN, United States | Makes it, tests 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
- Apr 24, 2026 · Class III · Lannett Company Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Lots: Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Primidone: every company that makes it
- Form
- tablet
- Strength
- 50 mg
- Approval
- ANDA ANDA084903
- On the market since
- May 24, 2001
- Package NDCs
71335-1158-171335-1158-271335-1158-3- Official label
- DailyMed (National Library of Medicine), updated Dec 28, 2021
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