Class II
Terminated
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
This recall has been terminated (originally issued November 27, 2013).
- Company
- Pfizer Us Pharmaceutical Group
- Recall Initiated
- September 4, 2013
- Posted
- November 27, 2013
- Recall Number
- D-014-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 31 bottles
- Firm Location
- New York, NY, United States
- Official Source
- View on FDA website ↗
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
US Nationwide
Lot / Code Info
Lot #: V121573, Exp 05/17
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