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Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fag...

FDA Recall #D-0023-2025 — Class II — September 25, 2024

Recall #D-0023-2025 Date: September 25, 2024 Classification: Class II Status: Terminated

Product Description

Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

Reason for Recall

cGMP violations

Recalling Firm

Fresenius Kabi Compounding, LLC — Canton, MA

Classification

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

Product Type

Drugs

Product Quantity

1008 bags

Distribution

Product was distributed to 125 direct accounts nationwide.

Code Information

Lot # C274-000037436, exp. date 30-Oct-24 C274-000038893, exp. date 7-Jan-25

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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