NuCare Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity
NuCare Pharmaceuticals is recalling Valsartan/HCTZ 320/25mg 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 involves a carcinogen impurity, which aligns with the 'Severe' criteria for significant health risks.
Plain-English summary
NuCare Pharmaceuticals, Inc. is recalling Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, NDC 68071-4183-3. 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 is identified by Lot # T11577 with an expiration date of 06/30/2019. The product was distributed to three customers in Florida and California. No specific illness or injury reports are mentioned in the source text.
Patients and healthcare providers should stop using the affected product and contact their healthcare provider for guidance on alternative treatments. The recall is classified as FDA Class II.
The recalled product
- Product
- Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3
- Manufacturer
- NuCare Pharmaceuticals Inc
- Category
- Drug — Antihypertensive
- Hazard
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 # T11577
- Exp. 06/30/2019
Distribution
Part of a larger recall action
This product is one of 3 recalled by NuCare Pharmaceuticals 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 manufacturer · NuCare Pharmaceuticals Inc
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Same hazard · carcinogen impurity
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