Recalls / Class II
Class IID-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
- Brand name
- Aldactone
- Generic name
- Spironolactone
- Active ingredient
- Spironolactone
- Route
- Oral
- NDCs
- 0025-1001, 0025-1041, 0025-1031
- FDA application
- NDA012151
- Affected lot / code info
- Lot #: V121573, Exp 05/17
Why it was recalled
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.
Recalling firm
- Firm
- Pfizer Us Pharmaceutical Group
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 31 bottles
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2013-09-04
- FDA classified
- 2013-11-20
- Posted by FDA
- 2013-11-27
- Terminated
- 2017-04-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-014-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.