Amerisource Recalls Paroxetine Tablets Due to Foreign Object Presence
Amerisource Health Services is recalling specific lots of Paroxetine tablets because they contain foreign tablets or capsules.
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: The recall involves a risk-of-harm product (foreign objects in medication) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Amerisource Health Services is recalling 74 cartons of Paroxetine Tablets, USP, 30mg. The product is distributed by American Health Packaging in Columbus, Ohio, and is identified by NDC 68084-046-01 and Lot 172291.
The recall was initiated due to the presence of foreign tablets or capsules in the product. The affected units were distributed nationwide in the USA.
Consumers and healthcare providers should check their inventory for the specific lot number and NDC listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer for further instructions.
The recalled product
- Product
- PAROXETINE (PAROXETINE)
- Brand
- PAROXETINE
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Prescription Drug
- Hazard
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 (1)
- Lot 172291
Distribution
Distributed nationwide across the United States.
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