Drug product
Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.
D-1362-2014
Product summary
- Event
- Event 67903
- Status
- Terminated
- Classification
- Class I
- Quantity
- 80 syringes
- Official record key
drug-enforcement:D-1362-2014
Official wording
Reason: Superpotent Drug: Product contains twice the stated amount of midazolam.
Code information: Lot #: E1016227C, Exp. 4/21/2014; E0433735C, Exp. 4/20/2014
Distribution pattern: IN
Derived failure modes
-
Potency or specification failure
Superpotent