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
Reported: November 30, 2016 Initiated: August 3, 2016 #D-0149-2017
Product Description
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
Reason for Recall
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Details
- Recalling Firm
- Zydus Pharmaceuticals USA Inc
- Units Affected
- 2,472 units
- Distribution
- Nationwide
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 2,472 units.
Why was this product recalled? ▼
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 30, 2016. Severity: Low. Recall number: D-0149-2017.
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