NuCare Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity
NuCare Pharmaceuticals is recalling specific lots of Valsartan/HCTZ 160/25mg 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 involves a carcinogen impurity in a prescription medication, which constitutes a significant health risk. Per the rubric, FDA Class II recalls involving significant injury or serious health risks are classified as Severe.
Plain-English summary
NuCare Pharmaceuticals, Inc. is voluntarily recalling Valsartan/HCTZ 160/25mg Tablets, 30-count jars, packaged in Orange, CA. The recall is limited to Lot # T11443 with an expiration date of 02/28/2019. The agency has classified this recall as Class II.
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 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. Consumers should check their medication for the specific lot number and expiration date listed above.
The recalled product
- Product
- Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,
- Manufacturer
- NuCare Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
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 # T11443
- Exp. 02/28/2019
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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