Bryant Ranch Recalls Valsartan 320 mg Tablets Due to Carcinogen Impurity
Bryant Ranch Prepack Inc. is recalling Valsartan 320 mg 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 aligns with the rubric criterion for Severe severity (FDA Class II with significant health risks).
Plain-English summary
Bryant Ranch Prepack Inc. is recalling Valsartan 320 mg tablets, packaged in 30-count, 90-count, and 28-count bottles. The recall is 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 includes NDC 63629-6905-1, NDC 63629-6905-2, and NDC 6362-96905-3. The recall covers Lot # 114319 (Exp. 10/18) and Lot # 109004 (Exp. 12/18). The product was distributed in Hawaii, Indiana, and Florida.
Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
- Manufacturer
- Bryant Ranch Prepack Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 990
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 (3)
- Lot # 114319
- Exp. 10/18 Lot # 109004
- Exp. 12/18
Distribution
Part of a larger recall action
This product is one of 3 recalled by Bryant Ranch Prepack Inc. 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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