D-0093-2019 Class II Terminated
FDA drug recall D-0093-2019 was initiated by RemedyRepack Inc. on Aug 24, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient. The recall status is terminated (terminated Oct 29, 2018). Affected quantity: 2 bottles of 90 tablets (180 tablets).
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 31, 2018
- Initiation Date
- Aug 24, 2018
- Termination Date
- Oct 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 bottles of 90 tablets (180 tablets)
Product Description
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
Reason for Recall
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Distribution Pattern
Product was distributed to a medical facility in South Carolina
Code Information
Lot # B0438903-052118 70518-1220-00
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0093-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026