Class III
Terminated
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- August 3, 2016
- Posted
- November 30, 2016
- Recall Number
- D-0149-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,472 units
- Firm Location
- Pennington, NJ, United States
Reason for Recall
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Distribution
Nationwide
Lot / Code Info
Lot #: MR3365, Exp. Feb 17
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