Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
Recall Number: D-0992-2018
Firm: Aidarex Pharmaceuticals LLC
Classification: Class III
Status: Terminated
Report Date: 20180801
Initiation Date: 20180627
Termination Date: 20191204
Reason for Recall
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Product Description
Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30