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HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL f...

FDA Recall #D-0410-2024 — Class II — November 9, 2023

Recall #D-0410-2024 Date: November 9, 2023 Classification: Class II Status: Terminated

Product Description

HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

SCA Pharmaceuticals, LLC — Windsor, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

909 syringes

Distribution

Nationwide in the USA

Code Information

Lot#: 1223048258 Exp 11/10/23; 1223048890 Exp 12/07/23; 1223049134 Exp 12/19/23

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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