Status
Terminated
Drug Enforcement D-011-2014
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.
Classification
Class II
Report Date
November 27, 2013
Termination Date
April 13, 2017
Product Information
- Product description
- Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1
- Product quantity
- 4848 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Greenstone Llc
- Address
-
100 Route 206 North
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-011-2014
- Event ID
- 66822
- Recall initiation date
- September 4, 2013
- Center classification date
- November 20, 2013
- Code info
- Lot #: V121211, Exp 03/31/2017
- More code info
- —