Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
Reported: April 5, 2023 Initiated: February 8, 2023 #D-0487-2023
Product Description
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
Reason for Recall
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Details
- Recalling Firm
- Apollo Care
- Units Affected
- 215 bags
- Distribution
- MO
- Location
- Columbia, MO
Frequently Asked Questions
What product was recalled? ▼
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25. Recalled by Apollo Care. Units affected: 215 bags.
Why was this product recalled? ▼
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 5, 2023. Severity: Moderate. Recall number: D-0487-2023.
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