Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.
Reported: August 1, 2018 Initiated: July 18, 2018 #D-0967-2018
Product Description
Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Details
- Recalling Firm
- MAJOR PHARMACEUTICALS
- Units Affected
- 4,556 cartons
- Distribution
- Nationwide.
- Location
- Livonia, MI
Frequently Asked Questions
What product was recalled? ▼
Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.. Recalled by MAJOR PHARMACEUTICALS. Units affected: 4,556 cartons.
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 1, 2018. Severity: Moderate. Recall number: D-0967-2018.
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