Pharmakon Pharmaceuticals recalls Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug…

Recall date

February 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0871-2016

FDA classification

Class I

Brand / firm

Pharmakon Pharmaceuticals

Sold / distributed

IN and IL

Why it was recalled

Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.