Primidone Tablets Recalled for Cross-Contamination with Acemetacin
Amerisource Health Services LLC is recalling Primidone 250 mg tablets (Lot 1027583, expiration 09/30/2027) due to cross-contamination with trace amounts of Acemetacin API during manufacturing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as Class III, which by definition indicates the contamination is unlikely to cause adverse health consequences. The source text reports only trace amounts of contamination with no reported illnesses or injuries.
Plain-English summary
Amerisource Health Services LLC is recalling Primidone Tablets, USP, 250 mg (Lot 1027583, expiration 09/30/2027) distributed nationwide. The active pharmaceutical ingredient (API) in this lot was contaminated with trace amounts of Acemetacin API due to cross-contamination during manufacturing.
Primidone is an anti-epileptic medication. The contamination was identified during quality control testing. Affected product includes carton NDC 68084-203-01 and individual dose NDC 68084-203-11, totaling 63,500 tablets that were distributed throughout the United States.
Patients currently taking this medication should contact their healthcare provider or pharmacist immediately to determine whether they received affected product from this lot. Patients should not stop their medication without consulting a healthcare professional. Healthcare providers and patients with product from this recall lot should report adverse events to the FDA's MedWatch program.
The recalled product
- Product
- PRIMIDONE (PRIMIDONE)
- Brand
- PRIMIDONE
- Manufacturer
- Amerisource Health Services LLC
- Hazard
- cross-contamination
- unintended-ingredient
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 1027583
- Exp 09/30/2027
Distribution
Distributed nationwide across the United States.