November 2013 FDA Recall Drug by Brookfield Prescription Center Inc
D-1252-2014 - Non-Sterility

This Class I drug recall was voluntarily initiated by Brookfield Prescription Center Inc on November 13, 2013 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed in WI and the recall is currently terminated.

Recall Number: D-1252-2014

Reason for Recall
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
Initiated
11-13-2013
Reported
04-30-2014
Quantity
25 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67026
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Brookfield Prescription Center 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-30-2014
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045.

Batch or Lot Expiration Information

Lot# : 10292013@15, Beyond Use Date: 11/28/2013