D-1137-2018 Class II Ongoing
FDA drug recall D-1137-2018 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: 89616 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 5, 2018
- Initiation Date
- Aug 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89616 bottles
Product Description
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution Pattern
Nationwide USA
Code Information
Batch: BV77D013, BV77C011, BV77D001, BV77D002, BV77D003, BV77D004, BV77D005, BV77D006, BV77D007, BV77D008, BV77D009 , BV77D010, BV77D011, BV77D012, BV77C009, BV77C010
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1137-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026