Class II · Moderate risk Ongoing
Glycopyrrolate Injection
Reason Presence of Particulate Matter: Hair was found in product
Glycopyrrolate
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
What was recalled
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.
- Recalling firm
- Brookfield Prescription Center Inc
- Origin
- WI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1252-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Glycopyrrolate recalls
See all
Class II · Moderate risk Ongoing
Glycopyrrolate Oral Solution
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Ongoing
Glycopyrrolate Oral Solution
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Glycopyrrolate
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Terminated
glycopyrrolate 1 mg/5 mL
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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