May 2016 FDA Recall Bromocriptine Mesylate by Zydus Pharmaceuticals Usa Inc
D-1491-2016 - Failed impurities/degradation specifications

This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on May 9, 2016 for the product Bromocriptine Mesylate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1491-2016

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.
Initiated
05-09-2016
Reported
09-14-2016
Quantity
14,808 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74233
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-01-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

68382-110-06 Bromocriptine Mesylate
68382-110-01 Bromocriptine Mesylate