FDA-Drug2016-09-14Class II
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
Zydus Pharmaceuticals USA Inc
Hazard
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.
Sold states
US Nationwide
Affected count
14,808 bottles
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1491-2016Don't want to check this manually?
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