FDA recall D-1252-2014

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.

Reason for recall

Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.

Distribution

WI

Key facts

Status

Terminated

Initiation date

2013-11-13

Report date

2014-04-30

Termination date

2014-05-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brookfield, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1252-2014