D-1075-2019 Class II Terminated
FDA drug recall D-1075-2019 was initiated by Legacy Pharmaceutical Packaging LLC on Mar 1, 2019 and is designated Class II. Reason for recall: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected. The recall status is terminated (terminated Sep 29, 2023). Affected quantity: 179,544 30-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 10, 2019
- Initiation Date
- Mar 1, 2019
- Termination Date
- Sep 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 179,544 30-count 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: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
Distribution Pattern
AZ, IN, TN
Code Information
Lots: 180190, 180191 (exp 10/2020) and 181597 (exp 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-1075-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026