Paroxetine 10 mg tablets recalled nationwide for out-of-specification impurities
Apotex Corp. is recalling Paroxetine 10 mg tablets nationwide due to out-of-specification impurities in an excipient. Affected lots expire 08/2024.
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: FDA Class II recall for out-of-specification impurities in a prescription medication's excipient. Class II classification indicates the defect could cause adverse health consequences, making this a risk-of-harm product.
Plain-English summary
Apotex Corp. is recalling Paroxetine Hydrochloride 10 mg tablets distributed nationwide. The recall affects bottles containing 30, 100, and 1,000 tablets. The recalled lot numbers are RV2375, RV2376, RV2377, RV2379, and RV2380, with an expiration date of August 2024. A total of 34,392 tablets are involved.
Testing revealed that the excipient Amadori Glucose adduct in the paroxetine tablets did not meet specified quality standards. Apotex initiated this recall due to the out-of-specification test results.
Patients taking paroxetine 10 mg should contact their pharmacist or healthcare provider to confirm whether their medication is from an affected lot. Do not stop taking your medication without consulting your healthcare provider. Return affected tablets to your pharmacy for proper disposal or replacement with an unaffected lot.
The recalled product
- Product
- PAROXETINE (PAROXETINE HYDROCHLORIDE)
- Brand
- PAROXETINE
- Manufacturer
- Apotex Corp.
- Category
- Drug
- Hazard
- Affected units
- 34,392
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: a)100 count bottle: RV2376
- RV2377
- b) 1000 count bottle: RV2379
- RV2380
- c) 30 count bottle: RV2375
- Exp. 08/2024
UPCs (4)
- 0360505010110
- 0360505008414
- 0360505009718
- 0360505008315
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Apotex Corp. 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 4 products in this recall →Related recalls
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Similar recalls
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FDA (Drugs) · 2023-12-06
- ModerateParoxetine 20 mg Tablets Recalled for Out-of-Specification Impurity
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