Recalls / Class II
Class IID-1137-2017
Product
Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8
- 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
- Lot #: Z701133, Exp 03/19
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
- 44800 bottles
- Distribution pattern
- Nationwide within United States
Timeline
- Recall initiated
- 2017-08-18
- FDA classified
- 2017-09-11
- Posted by FDA
- 2017-09-20
- Terminated
- 2020-01-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1137-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.