Greenstone Recalls Glipizide XL Tablets Due to Dissolution Failure
Greenstone LLC is recalling 22,529 bottles of Glipizide XL 5 mg tablets because a bulk lot failed a dissolution specification test.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Greenstone LLC is recalling 22,529 bottles of Glipizide XL (glipizide) extended release tablets, 5 mg, 500 count bottles. The affected product is identified by lot number V112000 and an expiration date of June 2016. The product was distributed nationwide in the United States, including Puerto Rico.
The recall was initiated because the bulk lot yielded an out-of-specification result at the 8-hour timepoint during an 18-month interval test. This indicates a failure to meet the required dissolution specifications for the extended-release formulation.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment. The recall is classified as Class III by the FDA.
The recalled product
- Product
- Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2
- Manufacturer
- Greenstone Llc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 22,529
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 (2)
- lot V112000
- EXP Jun 2016
Distribution
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