Drug product
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.
D-1565-2014
Product summary
- Event
- Event 68191
- Status
- Terminated
- Classification
- Class I
- Quantity
- 20 vials
- Official record key
drug-enforcement:D-1565-2014
Official wording
Reason: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Code information: Lot #: E21294K3C Exp Date: 6/29/2014
Distribution pattern: United States: TX, IL, MD, IN
Derived failure modes
-
Unknown
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.