FDAFDA · Food and drugs·Recall number D-0992-2018
Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
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: 51904-2, EXP: 01/31/2018; 51904-3, EXP: 02/28/2018; 51904-5, EXP: 03/31/2018; 52885-2, EXP: 03/31/2018, 53840-1, EXP: 5/28/2018.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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