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
Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
Lot numbers, UPCs & expiration codes
Lot #: V121207, V121208, Exp 03/31/2017
Where it was sold
Nationwide and Puerto Rico
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-010-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 4, 2013
- FDA report date
- Nov 27, 2013
- Quantity
- 2796 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Greenstone Llc
Original FDA data
Every field from FDA enforcement report D-010-2014, exactly as published.
Show all FDA fields
- City
- Peapack
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66822
- Address
- 100 Route 206 North
- Code information
- Lot #: V121207, V121208, Exp 03/31/2017
- Postal code
- 07977
- Report date
- Nov 27, 2013
- Product type
- Drugs
- Recall number
- D-010-2014
- Classification
- Class II
- Recalling firm
- Greenstone Llc
- Product quantity
- 2796 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
- Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 4, 2013
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2013