Class II
Terminated
Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1
- Company
- Greenstone Llc
- Recall Initiated
- September 4, 2013
- Posted
- November 27, 2013
- Recall Number
- D-011-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4848 bottles
- Firm Location
- Peapack, NJ, United States
Reason for Recall
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.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: V121211, Exp 03/31/2017
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