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Recall Observatory FDA recall evidence

Drug 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

D-0207-2017

November 02, 2016

Class III

Product summary

Firm
Zydus Pharmaceuticals USA Inc
Event
Event 75764
Status
Terminated
Classification
Class III
Quantity
16,356 bottles
Official record key
drug-enforcement:D-0207-2017

Official wording

Reason: Failed Dissolution Specifications; 6 month time point

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications