Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
Reported: August 22, 2018 Initiated: August 10, 2018 #D-1101-2018
Product Description
Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 21 bottles of 90 = 1890 tablets
- Distribution
- Product was distributed to three customers in FL and VA.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19. Recalled by RemedyRepack Inc.. Units affected: 21 bottles of 90 = 1890 tablets.
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 22, 2018. Severity: Moderate. Recall number: D-1101-2018.
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