Greenstone Recalls Sertraline Tablets Due to Incorrect Expiration Date Labeling
Greenstone LLC is recalling 585,096 bottles of sertraline HCl tablets because the expiration dates reflect a 36-month shelf life instead of the correct 24-month shelf life.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
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 2/5 (Moderate).
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, which corresponds to a moderate severity score for minor labeling errors that are unlikely to cause serious adverse health consequences.
Plain-English summary
Greenstone LLC is recalling 585,096 bottles of sertraline HCl tablets, 25 mg, 30-count bottles. The product is distributed nationwide and in Puerto Rico. The recall involves specific lots with expiration dates of 06/2015 and 02/2016.
The recall was initiated due to a labeling error where the expiration dates incorrectly reflect a 36-month shelf life instead of the correct 24-month shelf life. This discrepancy means the products may be used past their intended stability period.
Consumers who have these specific bottles of sertraline HCl tablets should stop using them and contact their healthcare provider or pharmacist for guidance. The affected lots are SASA12001-A, SASA12001-B, SASA13001-A, and SASA13002-A.
The recalled product
- Product
- sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1
- Manufacturer
- Greenstone LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 585,096
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 (6)
- Lot SASA12001-A
- exp. date 06/2015
- Lot SASA12001-B
- Lot SASA13001-A
- exp. date 02/2016
- Lot SASA13002-A
Distribution
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