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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: V121573, Exp 05/17
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-014-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 4, 2013
- FDA report date
- Nov 27, 2013
- Quantity
- 31 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Us Pharmaceutical Group
Original FDA data
Every field from FDA enforcement report D-014-2014, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 66124
- Address
- 235 E 42nd St
- Code information
- Lot #: V121573, Exp 05/17
- Postal code
- 10017-5703
- Report date
- Nov 27, 2013
- Product type
- Drugs
- Recall number
- D-014-2014
- Classification
- Class II
- Recalling firm
- Pfizer Us Pharmaceutical Group
- Product quantity
- 31 bottles
- Termination date
- Apr 13, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US Nationwide
- Recall initiation date
- Sep 4, 2013
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2013