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 Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
What was recalled
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
- Recalling firm
- Aidarex Pharmaceuticals LLC
- NDC code
- 33261-0693-90
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0053-2018
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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