Fentanyl Citrate IV Bags Recalled Due to Double-Dose Filling System Malfunction
Denver Solutions recalled 8,976 IV bags of fentanyl citrate nationwide due to a malfunction in the semi-automated filling system that could deliver double the intended dose.
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: FDA Class I recall classification, which per the severity rubric qualifies for Critical status. Class I is the FDA's highest designation for recalls involving serious health hazards.
Plain-English summary
Denver Solutions, LLC DBA Leiters Health is recalling 8,976 intravenous bags of fentanyl citrate (Item F3355, NDC 71449-072-41) distributed nationwide. The product is fentanyl citrate for intravenous use, supplied as 1000 micrograms per 100 milliliters of 0.9% sodium chloride solution.
The manufacturer initiated the recall because the semi-automated IV bag filling system can malfunction during production. When this malfunction occurs, the filling system can deliver a double dose of fentanyl citrate to individual IV bags.
The affected lots and corresponding expiration dates are Lot #2331062 (expires 02/08/2024), Lot #2331224 (expires 03/18/2024), and Lot #2331270 (expires 03/28/2024). The product was manufactured by Denver Solutions, LLC at 13796 Compark Boulevard, Englewood, Colorado 80112.
The recalled product
- Product
- FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug — Injectable / IV
- Affected units
- 8,976
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 (6)
- Lot #: 2331062
- Exp. Date: 02/08/2024
- 2331224
- Exp. Date 03/18/2024
- 2331270
- Exp. Date 03/28/2024.
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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