Class III
Terminated
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
This recall has been terminated (originally issued December 28, 2016).
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- November 2, 2016
- Posted
- December 28, 2016
- Recall Number
- D-0207-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,356 bottles
- Firm Location
- Pennington, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications; 6 month time point
Distribution
Nationwide
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
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