Drug product
Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31
D-014-2014
Product summary
- Event
- Event 66124
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31 bottles
- Official record key
drug-enforcement:D-014-2014
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 #: V121573, Exp 05/17
Distribution pattern: US Nationwide
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.