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.
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 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
Same brand · VALSARTAN
- ModerateCardinal Health Recalls Valsartan Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
Same manufacturer · Bryant Ranch Prepack Inc.
See all →- LowCephalexin Oral Suspension Recalled for Incorrect Labeling and Missing Dosage Information
FDA (Drugs) · 2024-06-12
- ModerateCephalexin oral suspension recalled for incorrect dose labeling
FDA (Drugs) · 2024-06-12
- LowCephalexin for Oral Suspension Recalled for Back Label Error
FDA (Drugs) · 2024-06-12
- ModerateCephalexin Oral Suspension Recalled for Incorrect Dosage Label
FDA (Drugs) · 2024-06-12
- ModerateCephalexin oral suspension recalled for incorrect label dosage amount
FDA (Drugs) · 2024-06-12
Same hazard · carcinogen impurity
See all →- SevereMacleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Carcinogen
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Irbesartan Bulk Ingredient Due to Carcinogen Impurity
FDA (Drugs) · 2018-11-07
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
Similar recalls
- SeverePrinston Recalls Valsartan Tablets Due to Carcinogen Impurity
FDA (Drugs) · 2018-08-01
- SevereRemedyRepack Recalls Valsartan 320 mg Tablets Due to Carcinogen Impurity
FDA (Drugs) · 2018-08-22
- SevereAvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity
FDA (Drugs) · 2018-09-05
- SevereNorthwind Pharmaceuticals Recalls Valsartan 320mg Due to Carcinogen Impurity
FDA (Drugs) · 2018-08-22
- SevereNorthwind Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity
FDA (Drugs) · 2018-08-22
- SevereAvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity in API
FDA (Drugs) · 2018-09-05