FDA-Drug2016-06-01Class I

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.

Pharmakon Pharmaceuticals
Hazard

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

Sold states
IN and IL
Affected count
75 Syringes
Manufactured in
14450 Getz Rd, N/A, Noblesville, IN, United States
Products
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 notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0871-2016

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