Paroxetine Hydrochloride Tablets Recalled for Out-of-Specification Impurity
Apotex Corp. is recalling Paroxetine Hydrochloride 40 mg tablets nationwide due to failed quality specifications. Testing found out-of-specification impurity levels in affected lot numbers.
What this means for you
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: FDA classified this as a Class II recall for an out-of-specification impurity in a prescription medication. No illnesses or injuries have been reported, placing this within the High severity tier for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Apotex Corp. is recalling Paroxetine Hydrochloride Tablets USP, 40 mg in 1,000-count bottles due to failed quality control specifications. The recall involves 4,074 units distributed nationwide. The affected lot numbers are RV0131, RV2387, RV2389, RW3296, and RV2388, with expiration date 08/2024.
The recall was initiated due to out-of-specification results for the excipient Amadori Glucose adduct of Paroxetine. This indicates the product failed to meet FDA manufacturing quality standards.
The FDA classified this as a Class II recall. No illnesses or injuries have been reported in connection with this medication. Patients with affected lot numbers should contact their healthcare provider for guidance.
The recalled product
- Product
- PAROXETINE (PAROXETINE HYDROCHLORIDE)
- Brand
- PAROXETINE
- Manufacturer
- Apotex Corp.
- Category
- Drug
- Hazard
- impurity
- quality-defect
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 numbers: RV0131
- RV2387
- RV2389
- RW3296
- RV2388
- Exp. 08/2024
UPCs (4)
- 0360505010110
- 0360505008414
- 0360505009718
- 0360505008315
Distribution
Distributed nationwide across the United States.
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