D-1283-2019 Class II Terminated
FDA drug recall D-1283-2019 was initiated by Golden State Medical Supply Inc. on May 1, 2019 and is designated Class II. Reason for recall: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer The recall status is terminated (terminated Feb 25, 2020). Affected quantity: 64,362 HDPE bottles.
Recall details
- Product Type
- Drugs
- Report Date
- May 29, 2019
- Initiation Date
- May 1, 2019
- Termination Date
- Feb 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64,362 HDPE bottles
Product description
Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated
Reason for recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Distribution pattern
IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.
Code information
GS015172 exp 06/2019 GS017634 02/2020, GS017653 exp 02/2020, GS017980 exp 02/2020, GS017276 exp 02/2020, GS017045 exp 02/2020,GS016726 exp 02/2020,
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1283-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026