Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
Reported: August 1, 2018 Initiated: June 27, 2018 #D-0992-2018
Product Description
Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
Reason for Recall
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Details
- Recalling Firm
- Aidarex Pharmaceuticals LLC
- Units Affected
- 25, 30-count bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Corona, CA
Frequently Asked Questions
What product was recalled? ▼
Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30. Recalled by Aidarex Pharmaceuticals LLC. Units affected: 25, 30-count bottles.
Why was this product recalled? ▼
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 1, 2018. Severity: Low. Recall number: D-0992-2018.
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