NuCare Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity
NuCare Pharmaceuticals is recalling specific lots of Valsartan/HCTZ 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 constitutes a significant health risk and aligns with the 'Severe' criteria for significant injury or high-risk contamination.
Plain-English summary
NuCare Pharmaceuticals, Inc. is recalling Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jars, under NDC 68071-4311-9. The recall is limited to Lot # U01779 with an expiration date of 04/30/2019.
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 agency has classified this recall as Class II.
The affected product was distributed to three customers in Florida and California. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for alternative treatment options or consult the recalling firm for further instructions.
The recalled product
- Product
- Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9
- Manufacturer
- NuCare Pharmaceuticals Inc
- Category
- Drug — Antihypertensive
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 # U01779
- Exp. 04/30/2019
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
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