NDC 68084-203
Primidone 250 mg tablet
On the label: American Health Packaging. It's repackaged: American Health Packaging rebottles it from Lannett Company, Inc.'s NDC 0527-1231.
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
- American Health Packaging, Columbus, OH, United States · repackages it
Recalls
- May 1, 2026 · Class III · Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Lots: Lot#: 1027583, Exp 09/30/2027 - May 1, 2026 · Class III · Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Lots: Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027 - 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, oral
- Strength
- 250 mg
- Approval
- ANDA ANDA084903
- On the market since
- Sep 17, 2007
- Package NDCs
68084-203-0168084-203-11- Official label
- DailyMed (National Library of Medicine), updated Oct 3, 2024
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