Recalls / Class II
Class IID-0091-2018
Product
Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01
- Brand name
- Paroxetine
- Generic name
- Paroxetine
- Active ingredient
- Paroxetine Hydrochloride
- Route
- Oral
- NDCs
- 68084-044, 68084-045, 68084-046, 68084-047
- FDA application
- ANDA077584
- Affected lot / code info
- Lot 172291
Why it was recalled
Presence of Foreign Tablets/Capsules.
Recalling firm
- Firm
- Amerisource Health Services
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 74 cartons (cartons of 100 individual unit doses)
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-10-24
- FDA classified
- 2017-11-21
- Posted by FDA
- 2017-11-29
- Terminated
- 2018-06-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0091-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.