Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, Th...
FDA Recall #D-0871-2016 — Class I — February 11, 2016
Product Description
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.
Reason for Recall
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Recalling Firm
Pharmakon Pharmaceuticals — Noblesville, IN
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
75 Syringes
Distribution
IN and IL
Code Information
Lot #: E52418EV11C, Exp 03/19/2016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated