Class II
Terminated
Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19
- Company
- Remedyrepack Inc.
- Recall Initiated
- August 10, 2018
- Posted
- August 22, 2018
- Recall Number
- D-1100-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9 bottles of 90 = 810 tablets
- Firm Location
- Indiana, PA, United States
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution
Product was distributed to three customers in FL and VA.
Lot / Code Info
Lot # B0335344-081717, exp. date 08/2018 Lot # B0363364-110917, exp. date 11/2018 Lot # B0391225-012218, exp. date 01/2019 Lot # B0408458-030618, exp. date 03/2019 Lot # B0384871-010318, exp. date 01/2019 Lot # B0436862-051518, exp. date 05/2019
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