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FDAFebruary 11, 2016drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

pharmakon pharmaceuticalspharmakon

UPCs

45183032278

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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