Aidarex Pharmaceuticals LLC recalls ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharma…
- Recall date
- September 5, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0053-2018
- FDA classification
- Class III
- Brand / firm
- Aidarex Pharmaceuticals LLC
- Sold / distributed
- Product was distributed in Florida
Why it was recalled
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Class III means the product violates regulations but is not likely to cause harm.
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.
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