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FDADecember 17, 2020drug

HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095

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

The hazard

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

What to do

FDA enforcement status: Terminated

Brands named

sca pharmaceuticalssca

UPCs

7000403001670004030018

Recall history

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

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HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 — Recall Details · AllClear