FDAFDA · Food and drugs·Recall number D-0990-2018
Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
Published August 1, 2018 · Recall initiated: June 27, 2018
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
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aidarex Pharmaceuticals LLC
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lots: 56698-1, EXP 1/31/2019; 56698-2, EXP 4/30/2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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