Major Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity
Major Pharmaceuticals is recalling specific lots of 80 mg Valsartan tablets because a carcinogen impurity was detected in the active ingredient.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a carcinogen impurity in a prescription drug, which constitutes a significant health risk. Per the rubric, FDA Class II recalls with significant injury or health risk reports are classified as Severe.
Plain-English summary
Major Pharmaceuticals is voluntarily recalling 5,464 cartons of Unit Dose Valsartan Tablets, USP, 80 mg. The recall affects specific lots distributed nationwide, including Lot# T-01270, T-01466, T-01500, T-01596, T-01625, T-01712, T-01795, and T-01807.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, a carcinogen impurity was detected in the active pharmaceutical ingredient (API) used to manufacture the drug product. The FDA has classified this recall as Class II.
Patients and healthcare providers should stop using the affected lots of Valsartan tablets and contact their healthcare provider for alternative treatment options. The recalled product is distributed by Major Pharmaceuticals in Livonia, Michigan.
The recalled product
- Product
- Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
- Manufacturer
- MAJOR PHARMACEUTICALS
- Category
- Drug — Prescription Medication
- Affected units
- 5,464
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by MAJOR PHARMACEUTICALS under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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