Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
Reported: November 27, 2013 Initiated: September 4, 2013 #D-010-2014
Product Description
Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
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.
Details
- Recalling Firm
- Greenstone Llc
- Units Affected
- 2796 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Peapack, NJ
Frequently Asked Questions
What product was recalled? ▼
Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.. Recalled by Greenstone Llc. Units affected: 2796 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 27, 2013. Severity: Moderate. Recall number: D-010-2014.
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