Denver Solutions, LLC, doing business as Leiters Health, is recalling 82,176 IV bags of fentanyl citrate, phenylephrine, and vancomycin. The recall was initiated because a malfunction in the semi-automated bag filling system may have resulted in some bags receiving a double dose of the medication, making them superpotent. These products are clinical drugs typically administered in hospitals or infusion centers.
A double dose of these medications poses a critical health risk. Overdose of fentanyl can cause life-threatening respiratory depression; phenylephrine can cause dangerously high blood pressure; and vancomycin can lead to severe kidney toxicity or hearing loss. No injuries have been reported to date.
Clinical / hospital-administered drug return process.
Quantity: 8,976 IV bags
Quantity: 13,920 IV bags
Quantity: 29,016 IV bags
Quantity: 12,564 IV bags
Quantity: 10,152 IV bags
Quantity: 7,548 IV bags
Image 1 - Labeling, fentanyl citrate PF 100mcg
Image 2 - Labeling, fentanyl citrate PF 100mcg
Image 3 - Labeling, fentanyl citrate PF 2500mcg
Image 4 - Labeling, fentanyl citrate PF 2500mcg
Image 5 - Labeling, phenylephrine hcl 20mg
Image 6 - Labeling, phenylephrine hcl 20mg
Image 7 - Labeling, phenylephrine hcl, 40mg
Image 8 - Labeling, phenylephrine hcl, 40mg
Image 9 - Labeling, vancomycin hcl pf 1.25g
Image 10 - Labeling, vancomycin hcl pf 1.25g
Image 11 - Labeling, Vancomycin hcl pf 1.5g
Image 12 - Labeling, Vancomycin hcl pf 1.5g
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release · Raw API Response
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