Greenstone Recalls Spironolactone Tablets Due to Unapproved Manufacturing Site Change
Greenstone LLC is recalling 2,796 bottles of Spironolactone 25 mg tablets because they were manufactured at an unapproved site, altering the dissolution profile.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Greenstone LLC is recalling 2,796 bottles of Spironolactone tablets, USP 25 mg, Rx only, 500 count. The affected product is distributed by Greenstone LLC in Peapack, NJ, and carries the NDC 59762-5011-2. The recall covers lots V121207 and V121208, which have an expiration date of 03/31/2017.
The recall was initiated because the distributed lots were manufactured at an alternate site that does not have an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This manufacturing site change resulted in changes to the dissolution profile of the medication. The product was distributed nationwide and in Puerto Rico.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
- Manufacturer
- Greenstone Llc
- Category
- Drug — Prescription Medication
- Affected units
- 2,796
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: V121207
- V121208
- Exp 03/31/2017
Distribution
Part of a larger recall action
This product is one of 2 recalled by Greenstone Llc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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