Warning
Fresenius Kabi Compounding Recalls thiamine HCl
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0335-2026Drug / Pharmaceutical
Fresenius Kabi Compounding Recalls thiamine HCl
Fresenius Kabi Compounding, LLC · Class II — Moderate Risk
Product Description
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
Reason for Recall
Lack of Assurance of Sterility
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database