Vancomycin IV bags recalled due to filling system malfunction causing double doses
Denver Solutions is recalling 10,152 Vancomycin IV bags nationwide because a filling system malfunction can deliver double doses of the antibiotic medication.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall for medication system malfunction capable of delivering double doses of an antibiotic. Per rubric, FDA Class I classification never falls below severity score 4.
Plain-English summary
Denver Solutions, LLC, operating as Leiters Health, is recalling 10,152 VANCOmycin HCl IV bags (Item F3206, NDC 71449-028-68) distributed nationwide. The product is a pre-filled IV bag containing 1.25 grams of vancomycin in 0.9% sodium chloride solution intended for intravenous use.
The company identified a malfunction in its semi-automated IV bag filling system that can cause the system to dispense a double dose of vancomycin into individual bags. This could result in patients receiving twice the intended medication dose.
The affected lots are: Lot 2331184 (Exp. 02/13/2024), Lot 2331185 (Exp. 02/10/2024), Lot 2331189 (Exp. 02/20/2024), Lot 2331191 (Exp. 02/24/2024), Lot 2331258 (Exp. 03/03/2024), and Lot 2331317 (Exp. 03/15/2024). The recall applies to product distributed across the United States.
Patients and healthcare providers who received doses from the affected lots should contact their healthcare provider immediately. Do not use remaining product from the recalled lots.
The recalled product
- Product
- VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug — Injectable
- Affected units
- 10,152
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 (12)
- Lot #: 2331184
- Exp. Date 02/13/2024
- 2331185
- Exp. Date 02/10/2024
- 2331189
- Exp. Date 02/20/2024
- 2331191
- Exp. Date 02/24/2024
- 2331258
- Exp. Date 03/03/2024
- 2331317
- Exp. Date 03/15/2024.
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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