Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3
Reported: August 15, 2018 Initiated: July 30, 2018 #D-1039-2018
Product Description
Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Details
- Recalling Firm
- NuCare Pharmaceuticals Inc
- Units Affected
- N/A
- Distribution
- Distributed to three customers in Fl and CA
- Location
- Orange, CA
Frequently Asked Questions
What product was recalled? ▼
Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3. Recalled by NuCare Pharmaceuticals Inc. Units affected: N/A.
Why was this product recalled? ▼
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 15, 2018. Severity: Moderate. Recall number: D-1039-2018.
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