Bryant Ranch Recalls Valsartan Tablets Due to Carcinogen Impurity
Bryant Ranch Prepack Inc. is recalling specific lots of Valsartan 320 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
What this means for you
Illness, injury, or structural failure has been reported. 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 the detection of a carcinogen impurity in a prescription drug represents a significant health risk, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
Bryant Ranch Prepack Inc. is recalling Valsartan 320 mg tablets, 90-count bottles (NDC 71335-0567-2). The recall is limited to Lot # 120879 with an expiration date of 10/19. The product is a prescription-only medication packaged by Bryant Ranch in Burbank, CA.
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 affected product was distributed in Hawaii (HI), Indiana (IN), and Florida (FL). Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatments or replacements.
The recalled product
- Product
- VALSARTAN (VALSARTAN)
- Brand
- VALSARTAN
- Manufacturer
- Bryant Ranch Prepack Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 90
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 # 120879
- Exp 10/19
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.
See all 3 products in this recall →Related recalls
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Same hazard · carcinogen impurity
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- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
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