Drug recall D-1491-2016

Class II Terminated reported Sep 14, 2016

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.

Lots and codes

Lot # MP993, Exp10/16; MR2704, Exp 02/17; MR6851, MR8100; Exp 07/17 and MR1210, Exp 12/17

Recall details

Recalling firm
Zydus Pharmaceuticals USA Inc, Pennington, NJ
Quantity
14,808 bottles
Distribution
US Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 9, 2016
Terminated
May 1, 2018

Related products