PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 30, 2024 Initiated: September 25, 2024 #D-0023-2025

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

Details

Units Affected
1008 bags
Distribution
Product was distributed to 125 direct accounts nationwide.
Location
Canton, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Fresenius Kabi Compounding, LLC. Units affected: 1008 bags.
Why was this product recalled?
cGMP violations
Which agency issued this recall?
This recall was issued by the FDA Drug on October 30, 2024. Severity: Moderate. Recall number: D-0023-2025.