D-1020-2018 Class II Terminated
FDA drug recall D-1020-2018 was initiated by RemedyRepack Inc. on Jul 17, 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 17, 2018). Affected quantity: 4 HDPE 90-count bottles (360 tablets).
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 8, 2018
- Initiation Date
- Jul 17, 2018
- Termination Date
- Oct 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 HDPE 90-count bottles (360 tablets)
Product Description
Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution Pattern
Product was distributed to 3 medical facilities in Florida.
Code Information
Lot # B0318652-070617; Exp. 07/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1020-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026