FentaNYL Citrate IV Bags Recalled Due to Double-Dose Filling System Malfunction
FentaNYL citrate intravenous bags are recalled nationwide because a semi-automated filling system can malfunction and deliver double the intended dose. Patients and healthcare providers should immediately quarantine affected lots.
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: This is an FDA Class I drug recall, which requires a minimum severity score of 4 per the rubric. Although no illnesses or injuries are explicitly reported in the source text, the potential hazard—FentaNYL at double the intended dose—poses serious risk of overdose and life-threatening complications.
Plain-English summary
Denver Solutions, LLC (doing business as Leiters Health) is recalling FentaNYL citrate PF intravenous bags distributed nationwide. The product is FentaNYL citrate 2500 mcg per 250 mL 0.9% Sodium Chloride solution (10 mcg per mL) for intravenous use only, Item F3342, NDC 71449-072-82. Approximately 13,920 IV bags are subject to recall.
The semi-automated IV bag filling system can malfunction and provide a double dose of FentaNYL in affected bags. Receipt of double the intended dose poses a serious risk of overdose.
The recall affects five lot numbers: Lot 2330988 (expires 01/31/2024), Lot 2331058 (expires 02/18/2024), Lot 2331150 (expires 03/10/2024), Lot 2331231 (expires 03/24/2024), and Lot 2331289 (expires 03/30/2024).
Healthcare providers and facilities should immediately quarantine FentaNYL citrate from the affected lots and not administer them to patients. Patients who have received FentaNYL citrate from affected lots should contact their healthcare provider.
The recalled product
- Product
- FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug — Injectable / Intravenous
- Affected units
- 13,920
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 (10)
- Lot #: 2330988
- Exp. Date 01/31/2024
- 2331058
- Exp. Date 02/18/2024
- 2331150
- Exp. Date 03/10/2024
- 2331231
- Exp. Date 03/24/2024
- 2331289
- Exp. Date 03/30/2024.
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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