FDA Recall D-1252-2014
Brookfield Prescription Center Inc · Brookfield, WI
Class I — life-threatening Terminated 198 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1252-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- WI
- Recall initiated
- 2013-11-13
- Classified by FDA Center
- 2014-04-21
- FDA published
- 2014-04-30
- Terminated
- 2014-05-30
- Recalling firm
- Brookfield Prescription Center Inc
- Firm location
- Brookfield, WI