Drug product
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.
D-1566-2014
Product summary
- Event
- Event 68191
- Status
- Terminated
- Classification
- Class I
- Quantity
- 10/50 mL bags, 40/100 mL bags
- Official record key
drug-enforcement:D-1566-2014
Official wording
Reason: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Code information: A) Lot #: E21294DK1C; Exp Date: 05/22/2014 B) Lot #: E21294DK3C; Exp Date: 06/08/2014
Distribution pattern: United States: TX, IL, MD, IN
Derived failure modes
-
Unknown
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.