Drug product
Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
D-010-2014
Product summary
- Firm
- Greenstone Llc
- Event
- Event 66822
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2796 bottles
- Official record key
drug-enforcement:D-010-2014
Official wording
Reason: 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.
Code information: Lot #: V121207, V121208, Exp 03/31/2017
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
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.