Recalls / Class II
Class IID-010-2014
Product
Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
- Affected lot / code info
- Lot #: V121207, V121208, Exp 03/31/2017
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.
Recalling firm
- Firm
- Greenstone Llc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Route 206 North, Peapack, New Jersey 07977
Distribution
- Quantity
- 2796 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-09-04
- FDA classified
- 2013-11-20
- Posted by FDA
- 2013-11-27
- Terminated
- 2017-04-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-010-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.