Lannett Company Inc.: Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Lannett Company Inc.
- Product
- Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
- Reason / hazard
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- USA Nationwide
- Recall initiated
- 2026-04-24
- Code info
- 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.
- Product quantity
- 44865 bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Seymour
- State
- IN
- Country
- United States
- Event id
- 98791
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