US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 17, 2020 (6 years ago)

HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022

Recalling firm
SCA Pharmaceuticals
Origin
CT, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0215-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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