FDA Recalls Vancomycin IV Bags Due to Dosing System Malfunction
Denver Solutions is recalling 7,548 IV bags of vancomycin due to a manufacturing system malfunction that can deliver double doses. The product was distributed nationwide.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, the agency's highest classification for drug recalls, indicating serious potential health consequences. The manufacturing system malfunction can deliver double doses of vancomycin, a potent IV antibiotic.
Plain-English summary
FDA issued a Class I recall of vancomycin IV bags manufactured by Denver Solutions, LLC (DBA Leiters Health) due to a semi-automated IV bag filling system malfunction that can provide double doses of the drug.
The affected product is VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride in 250 mL IV bags (Item F3208, NDC 71449-029-68). The recall affects 7,548 IV bags across four manufacturing lots: 2331140 (exp. 02/08/2024), 2331188 (exp. 02/15/2024), 2331261 (exp. 03/05/2024), and 2331287 (exp. 03/14/2024). These products were distributed nationwide within the United States.
Healthcare facilities that received this product should immediately discontinue use and verify their inventory against the recalled lot numbers. Any patients who may have received a double dose of vancomycin should consult with their healthcare provider immediately.
The recalled product
- Product
- VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug — Injectable / Antibiotic
- Hazard
- overdose
- 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 (8)
- Lot #: 2331140
- Exp. Date 02/08/2024
- 2331188
- Exp. Date 02/15/2024
- 2331261
- Exp. Date 03/05/2024
- 2331287
- Exp. Date 03/14/2024.
Distribution
Distributed nationwide across the United States.
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