Paroxetine Tablets Recalled Due to Manufacturing Specification Failure
Apotex Corp. is recalling Paroxetine Hydrochloride 20 mg tablets nationwide due to out-of-specification impurity levels in affected lots. No illnesses have been reported.
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: FDA Class II recall with no reported illnesses or adverse events. The out-of-specification impurity represents a manufacturing quality control failure rather than a confirmed safety hazard, consistent with a precautionary recall classification.
Plain-English summary
Apotex Corp. is recalling approximately 48,623 units of Paroxetine Hydrochloride Tablets USP, 20 mg in 100-count and 1000-count bottles distributed nationwide. The recall was initiated due to out-of-specification results for an impurity known as Amadori Glucose adduct of Paroxetine.
The affected lot numbers are RV2384 and RV2385 (100-count bottles) and RV2396 and RV2397 (1000-count bottles), all bearing an expiration date of August 2024. The Amadori Glucose adduct is a degradation product that can form in the medication and was found to exceed allowable specification limits.
No illnesses or adverse events have been reported. Patients who have received affected medication should contact their pharmacist or healthcare provider. Patients should not discontinue the medication without consulting their healthcare professional.
The recalled product
- Product
- PAROXETINE (PAROXETINE HYDROCHLORIDE)
- Brand
- PAROXETINE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Antidepressant
- Hazard
- impurity
- degradation-product
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 (5)
- Lot numbers: a)100 count bottle: RV2384
- RV2385
- b) 1000 count bottle: RV2396
- RV2397
- Exp. 08/2024
UPCs (4)
- 0360505010110
- 0360505008414
- 0360505009718
- 0360505008315
Distribution
Distributed nationwide across the United States.
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