CLASS I Drug recall · Reported 30 Apr 2014 · FDA Enforcement Report
Glycopyrrolate (MDV) 0.2 MG/ML Injectable Vials recalled
Brookfield Prescription Center is recalling Glycopyrrolate (MDV) 0.2 MG/ML Injectable Vials, Sterile Serum Vials/Sterile Syringes, distributed in Wisconsin. The recall was initiated on 13 Nov 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1252-2014
- FDA event ID
- 67026
- Recalling firm
- Brookfield Prescription Center, Brookfield, WI
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 13 Nov 2013
- FDA classified
- 21 Apr 2014
- Reported
- 30 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Nov 2013 | Recall initiated by company | |
| 21 Apr 2014 | Classified by FDA | +159 days |
| 30 Apr 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
WI
Questions about this recall
Why was it recalled?
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
Which lots are affected?
Lot #: 10292013@15, Beyond Use Date: 11/28/2013
Where was it sold?
WI
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.