Drug 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.
D-1252-2014
Product summary
- Event
- Event 67026
- Status
- Terminated
- Classification
- Class I
- Quantity
- 25 Vials
- Official record key
drug-enforcement:D-1252-2014
Official wording
Reason: Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
Code information: Lot #: 10292013@15, Beyond Use Date: 11/28/2013
Distribution pattern: WI
Derived failure modes
-
Unknown
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.