Paroxetine Tablets Recalled Due to Out-of-Specification Impurity Levels
Paroxetine tablets are being recalled for failing specification tests due to higher-than-acceptable levels of a degradation impurity. Approximately 1,941 bottles distributed nationwide are affected.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for pharmaceutical impurity. The classification indicates potential risk of harm, but no illnesses or injuries have been reported, consistent with the rubric criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Paroxetine tablets, USP, 10 mg are being recalled due to failed quality control specifications. Manufactured by Apotex Inc. and packaged by GSMS Inc., certain lots contain out-of-specification levels of Amadori Glucose adduct of Paroxetine, a degradation impurity.
Approximately 1,941 bottles are affected, distributed nationwide in the United States. The recalled product is available in 30-count (NDC 60429-734-30), 90-count (NDC 60429-734-90), and 1,000-count (NDC 60429-734-10) bottles with expiration dates of August 31, 2024.
Consumers with affected medication should contact their pharmacy or healthcare provider for guidance. The recalling firm is Golden State Medical Supply Inc.
The recalled product
- Product
- PAROXETINE (PAROXETINE HYDROCHLORIDE)
- Brand
- PAROXETINE
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug
- Hazard
- Affected units
- 1,941
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 (9)
- Lot # a) Lot GS041383
- GS042141
- Exp. 08/31/2024
- b) Lot GS040841
- Lot GS041384
- Lot GS042039
- c) Lot GS040910
- Lot GS041621
- Lot GS042237
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Golden State Medical Supply Inc. 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.
See all 3 products in this recall →Related recalls
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Similar recalls
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- ModerateParoxetine Tablets Recalled Due to Manufacturing Specification Failure
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