Paroxetine 40 mg tablets recalled for out-of-specification impurities
Golden State Medical Supply Inc. is recalling Paroxetine 40 mg tablets due to failed impurity specifications. A total of 5,626 bottles were distributed nationwide.
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: This is an FDA Class II pharmaceutical recall based on quality-control testing rather than reported illnesses or injuries. The out-of-specification impurities represent a precautionary concern, warranting a Moderate-severity classification consistent with voluntary precautionary recalls.
Plain-English summary
Golden State Medical Supply Inc. is recalling Paroxetine 40 mg tablets, USP, due to failed impurity and degradation specifications. The tablets were manufactured by Apotex Inc. in Toronto, Ontario, Canada, and packaged by GSMS Inc. in Camarillo, California.
The recall affects three package sizes: 30-count bottles (NDC 60429-737-30), 90-count bottles (NDC 60429-737-90), and 1,000-count bottles (NDC 60429-737-10). Affected lot numbers include GS036488, GS037091, GS037701, GS037090, GS037702, GS036677, GS037117, and GS037699, all with an expiration date of August 31, 2024.
Out-of-specification results were detected for the excipient Amadori Glucose adduct of Paroxetine, indicating the presence of degradation products beyond acceptable limits. A total of 5,626 bottles were distributed nationwide throughout the United States.
The recalled product
- Product
- PAROXETINE (PAROXETINE HYDROCHLORIDE)
- Brand
- PAROXETINE
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Psychiatric / SSRI
- Hazard
- Affected units
- 5,626
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) GS036488
- GS037091
- GS037701
- Exp. 08/31/2024
- b) GS037090
- GS037702
- c) GS036677
- GS037117
- GS037699
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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