D-1100-2018 Class II Terminated
FDA drug recall D-1100-2018 was initiated by RemedyRepack Inc. on Aug 10, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. The recall status is terminated (terminated Oct 12, 2018). Affected quantity: 9 bottles of 90 = 810 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 22, 2018
- Initiation Date
- Aug 10, 2018
- Termination Date
- Oct 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 bottles of 90 = 810 tablets
Product Description
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
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution Pattern
Product was distributed to three customers in FL and VA.
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1100-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026