Reported Nov 27, 2013 · Terminated
Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC:…
Greenstone LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Greenstone Llc · 100 Route 206 North · Peapack, NJ · 07977
Is this the product you have?
- Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle
- Distributed ByGreenstone LLC, Peapack, NJ 07977
- NDC59762-5011-2
- Lot codes and dates
Lot #: V121207V121208Exp 03/31/2017
- Amount recalled
- 2796 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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