D-1139-2018 Class II Ongoing
FDA drug recall D-1139-2018 was initiated by Torrent Pharma Inc. on Aug 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 ongoing. Affected quantity: 46272 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 5, 2018
- Initiation Date
- Aug 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46272 bottles
Product Description
Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution Pattern
Nationwide USA
Code Information
Batch: BV65D002, BV65C002, BV65C003, BV65C004, BV65D001
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1139-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026