Zydus Pharmaceuticals USA Inc recalls Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad
Recalled September 14, 2016 · FDA recall D-1491-2016 · Zydus Pharmaceuticals USA
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. · FDA Class II
Units
14,808 bottles
Sold at
US Nationwide
Description
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.
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
Manufacturer(s)
Zydus Pharmaceuticals USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →