Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701

FDA recall notice · announced August 8, 2018 · Remedyrepack

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Notes

Distribution: Product was distributed to 3 medical facilities in Florida.
Lot/code information: Lot # B0383153-122917; Exp. 12/18
Quantity: 3 HDPE 90-count bottles (270 tablets)
Status: Terminated
Products in this recall event:
- Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701 (D-1020-2018)
- Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701 (D-1021-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.