Product: Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06
Reason for recall: Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Recall initiated: 20160509
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated