Recalls / Class III
Class IIID-0207-2017
Product
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
- Brand name
- Bupropion
- Generic name
- Bupropion
- Active ingredient
- Bupropion Hydrochloride
- Route
- Oral
- NDCs
- 68382-353, 68382-354
- FDA application
- ANDA201567
- Affected lot / code info
- a) MS1667 exp 01/2018; M601708, exp 03/2018; b) MS1667, MS1668, MS1669, exp 01/2018; M601515, M601516, exp 03/2018; M602920, M602921, M605399, M602937, M602938, M602939, exp 04/2018; M603988, exp 06/2018
Why it was recalled
Failed Dissolution Specifications; 6 month time point
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
- 16,356 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-02
- FDA classified
- 2016-12-20
- Posted by FDA
- 2016-12-28
- Terminated
- 2020-07-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0207-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.