Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for ...
FDA Recall #D-1252-2014 — Class I — November 13, 2013
Product Description
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.
Reason for Recall
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
Recalling Firm
Brookfield Prescription Center Inc — Brookfield, WI
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
25 Vials
Distribution
WI
Code Information
Lot #: 10292013@15, Beyond Use Date: 11/28/2013
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated