Drug product
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.
D-1567-2014
Product summary
- Event
- Event 68191
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Syringes
- Official record key
drug-enforcement:D-1567-2014
Official wording
Reason: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Code information: Lot #: E131210.212 Exp: 07/14/2014
Distribution pattern: United States: TX, IL, MD, IN
Derived failure modes
-
Unknown
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.