Drug recall D-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
Reason for recall
Failed Dissolution Specifications; 6 month time point
Lots and codes
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
Recall details
- Recalling firm
- Zydus Pharmaceuticals USA Inc, Pennington, NJ
- Quantity
- 16,356 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 2, 2016
- Terminated
- July 23, 2020
Related products
- bupropion – drug information
- NDC 68382-353 bupropion · Bupropion Hydrochloride 150 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-354 bupropion · Bupropion Hydrochloride 300 mg/1 · Zydus Pharmaceuticals USA Inc.