D-1263-2019 Class II Ongoing
FDA drug recall D-1263-2019 was initiated by Legacy Pharmaceutical Packaging LLC on Apr 24, 2019 and is designated Class II. Reason for recall: CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API) The recall status is ongoing. Affected quantity: 60,012 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2019
- Initiation Date
- Apr 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60,012 bottles
Product Description
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54
Reason for Recall
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Distribution Pattern
TN, AZ
Code Information
Lot 181598; 02/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1263-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026