FDA-Drug2016-12-28Class III
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
Zydus Pharmaceuticals USA Inc
Hazard
Failed Dissolution Specifications; 6 month time point
Sold states
Nationwide
Affected count
16,356 bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0207-2017Don't want to check this manually?
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