Drug recall: Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC…
Class II FDA enforcement event 66822. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Greenstone Llc started this drug recall on 4 Sep 2013. The firm address in the FDA record is in Peapack, NJ. FDA put the recall in Class II. FDA event 66822 has 2 product records. The first FDA enforcement report date is 27 Nov 2013. The record gives the status Terminated, with the termination date 13 Apr 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide and Puerto Rico
Recalling firm
Greenstone Llc, Peapack, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-010-2014 | Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2. | 2796 bottles | Class II | Terminated | 27 Nov 2013 |
| D-011-2014 | Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1 | 4848 bottles | Class II | Terminated | 27 Nov 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2013
- 370
- Share of these events in Class II
- 56%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Jan 2026 | methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: | Drug | Class II | 1 |
| 6 Mar 2014 | Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC | Drug | Class I | 1 |
| 5 Nov 2013 | sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 079 | Drug | Class II | 1 |
| 4 Nov 2013 | Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., P | Drug | Class III | 1 |
| 1 Nov 2013 | Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ, | Drug | Class II | 1 |
Official channels
- FDA enforcement report D-010-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 66822. https://recallregister.com/fda/ii/66822/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide and Puerto Rico
- What quantity of product is in FDA event 66822?
- The event has 2 product records. The first record gives this quantity:
2796 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2013 have the same class?
- 56% of the 370 drug events that started in 2013 are in Class II.