Recall Enforment Report D-011-2014
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Greenstone Llc, originally initiated on 09-04-2013 for the product Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1 The product was recalled due to 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.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-011-2014 | 09-04-2013 | 11-27-2013 | Class II | 4848 bottles | Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1 | 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. | Terminated |
| D-010-2014 | 09-04-2013 | 11-27-2013 | Class II | 2796 bottles | Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2. | 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. | Terminated |
