Drug product
Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.
D-0871-2016
Product summary
- Event
- Event 73297
- Status
- Terminated
- Classification
- Class I
- Quantity
- 75 Syringes
- Official record key
drug-enforcement:D-0871-2016
Official wording
Reason: Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Code information: Lot #: E52418EV11C, Exp 03/19/2016
Distribution pattern: IN and IL
Derived failure modes
-
Potency or specification failure
Out of specification