Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90
Reported: July 17, 2019 Initiated: June 14, 2019 #D-1465-2019
Product Description
Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90
Reason for Recall
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Details
- Recalling Firm
- Golden State Medical Supply Inc.
- Units Affected
- 32,835 bottles (2,955,150 tablets)
- Distribution
- US Nationwide One (1) US government account. No foreign accounts.
- Location
- Camarillo, CA
Frequently Asked Questions
What product was recalled? ▼
Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90. Recalled by Golden State Medical Supply Inc.. Units affected: 32,835 bottles (2,955,150 tablets).
Why was this product recalled? ▼
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 17, 2019. Severity: Moderate. Recall number: D-1465-2019.
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