Major Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity
Major Pharmaceuticals is recalling specific lots of 160 mg Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical 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 is classified as FDA Class II and involves a carcinogen impurity, which meets the rubric criteria for a Severe rating due to the significant potential for serious injury.
Plain-English summary
Major Pharmaceuticals is voluntarily recalling 4,556 cartons of Unit Dose Valsartan Tablets, USP, 160 mg. The affected products are distributed nationwide and include specific lot numbers T-01269, T-01524, T-01646, T-01668, and T-01788. The recall is classified as FDA Class II.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product. The source text does not specify the name of the impurity or report any illnesses or injuries associated with the use of these products.
Patients and healthcare providers should stop using the affected lots of Valsartan tablets and contact their healthcare provider for guidance on alternative treatment options. The recall is limited to the specific lot numbers and NDC codes listed in the official notice.
The recalled product
- Product
- Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.
- Manufacturer
- MAJOR PHARMACEUTICALS
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 4,556
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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