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Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx o...

FDA Recall #D-0394-2024 — Class II — November 9, 2023

Recall #D-0394-2024 Date: November 9, 2023 Classification: Class II Status: Terminated

Product Description

Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135

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

381 Bags

Distribution

Nationwide in the USA

Code Information

Lot #: 1223049625, Exp 1/24/24

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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