Zydus Pharmaceuticals USA Inc recalls Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedaba…

Recall date

May 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1491-2016

FDA classification

Class II

Brand / firm

Zydus Pharmaceuticals USA Inc

Sold / distributed

US Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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