Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Enalapril Maleate Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Stability Specifications
What was recalled
Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01
- Recalling firm
- Amerisource Health Services
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0074-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Enalapril recalls
See all
Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason CGMP Deviations
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