FDA-Drug2018-08-01Class III

Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90

Aidarex Pharmaceuticals LLC
Hazard

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Sold states
Distributed Nationwide in the USA
Affected count
61, 90-count bottles
Manufactured in
595 N Smith Ave, N/A, Corona, CA, United States
Products
Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0991-2018

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