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FDAApril 20, 2016drug

HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0933-75

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

The hazard

Lack of Assurance of Sterility

What to do

FDA enforcement status: Terminated

Brands named

pharmakon pharmaceuticalspharmakon

UPCs

45183093375

Recall history

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

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HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0933-75 — Recall Details · AllClear