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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 7,548
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.
Part of a larger recall action
This product is one of 6 recalled by Denver Solutions, LLC DBA Leiters Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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