FDAFDA · Food and drugs·Recall number D-0053-2018
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
Published November 1, 2017 · Recall initiated: September 5, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Aidarex Pharmaceuticals LLC
- Distributor
- Product was distributed in Florida
- Lot
- Lot #: 55097-2, 56085-1, Exp 11/30/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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