Drug recall D-014-2014
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
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.
Lots and codes
Lot #: V121573, Exp 05/17
Recall details
- Recalling firm
- Pfizer Us Pharmaceutical Group, New York, NY
- Quantity
- 31 bottles
- Distribution
- US Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 4, 2013
- Terminated
- April 13, 2017
Related products
- Aldactone – drug information
- NDC 0025-1031 Aldactone · Spironolactone 100 mg/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 0025-1041 Aldactone · Spironolactone 50 mg/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 0025-1001 Aldactone · Spironolactone 25 mg/1 · Pfizer Laboratories Div Pfizer Inc