FDAFDA · Food and drugs·Recall number D-010-2014
Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
Published November 27, 2013 · Recall initiated: September 4, 2013
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
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Greenstone Llc
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: V121207, V121208, Exp 03/31/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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