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FDAMay 18, 2017drug

HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55

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

The hazard

Lack of assurance of sterility: Product bags leaking at seam.

What to do

FDA enforcement status: Terminated

Brands named

sca pharmaceuticalssca

UPCs

70004030055

Recall history

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

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HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55 — Recall Details · AllClear