Injectable Thiamine Drug Recalled for Manufacturing Compliance Violations
Fresenius Kabi Compounding recalled 1,008 bags of Thiamine HCl injectable due to current good manufacturing practice violations. The recall was voluntary and nationwide distribution affected 125 accounts.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall is for manufacturing compliance violations without reported illnesses or injuries. Since no harm has been reported and the hazard is based on potential manufacturing defects rather than confirmed contamination, the score is High.
Plain-English summary
Fresenius Kabi Compounding, LLC recalled 1,008 bags of Thiamine HCl 0.9% Sodium Chloride Injection USP (500 mg per 100 mL) in September 2024. The affected lots are C274-000037436 (expiration October 30, 2024) and C274-000038893 (expiration January 7, 2025), with NDC 71506-079-56.
The recall was initiated due to violations of current good manufacturing practice (cGMP) standards. The manufacturer determined the product did not meet manufacturing compliance requirements.
The product was distributed nationwide to 125 direct accounts. The manufacturer voluntarily initiated this recall, which was terminated in August 2025.
The recalled product
- Product
- 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
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug — Injectable Drug
- Hazard
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # C274-000037436
- exp. date 30-Oct-24 C274-000038893
- exp. date 7-Jan-25
Distribution
Distributed nationwide across the United States.
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