Recalls / Class II
Class IID-0487-2023
Product
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
- Affected lot / code info
- Lot #: AC-016581
Why it was recalled
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Recalling firm
- Firm
- Apollo Care
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 3801 Mojave Ct Ste 101, N/A, Columbia, Missouri 65202-4042
Distribution
- Quantity
- 215 bags
- Distribution pattern
- MO
Timeline
- Recall initiated
- 2023-02-08
- FDA classified
- 2023-03-24
- Posted by FDA
- 2023-04-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0487-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.