D-1146-2018 Class II Terminated
FDA drug recall D-1146-2018 was initiated by RemedyRepack Inc. on Aug 20, 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 10, 2018). Affected quantity: 3 bottles of 90 tablets (270 tablets overall).
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 5, 2018
- Initiation Date
- Aug 20, 2018
- Termination Date
- Oct 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 bottles of 90 tablets (270 tablets overall)
Product Description
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
Reason for Recall
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Distribution Pattern
South Carolina
Code Information
70518-1220-0; Lot #: B0476653-080218; Exp. Date: 08/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1146-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026