Recalls / Class II
Class IID-0101-2018
Product
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
- Brand name
- Paroxetine
- Generic name
- Paroxetine
- Active ingredient
- Paroxetine Hydrochloride Hemihydrate
- Route
- Oral
- NDCs
- 68382-001, 68382-097, 68382-098, 68382-099
- FDA application
- ANDA077584
- Affected lot / code info
- a) Z701308, b) Z701309, c) Z701310 exp April 2019
Why it was recalled
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 19812 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-11-20
- FDA classified
- 2017-11-30
- Posted by FDA
- 2017-12-06
- Terminated
- 2020-09-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0101-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.