Aidarex Pharmaceuticals LLC recalls Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India.…
- Recall date
- June 27, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0992-2018
- FDA classification
- Class III
- Brand / firm
- Aidarex Pharmaceuticals LLC
- Sold / distributed
- Distributed Nationwide in the USA
Why it was recalled
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
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