Preferred Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity
Preferred Pharmaceuticals is recalling Valsartan Tablets USP 320 mg 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 aligns with the rubric criteria for Severe severity (FDA Class II with significant health risk).
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Valsartan Tablets USP 320 mg, 90-count, plastic child-resistant bottles (NDC 68788-6882-9). 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 affected product consists of 9 bottles, each containing 90 tablets. The products were distributed to one distributor in Alabama, who may have further distributed the product to the consumer level. The specific lot number is G2017F.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is classified as FDA Class II.
The recalled product
- Product
- Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
- Manufacturer
- Preferred Pharmaceuticals, Inc
- Category
- Drug — Prescription Medication
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 (1)
- Lot # G2017F NDC 68788-6882-9
Distribution
Distributed in 1 state:
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