Recalls / Class II
Class IID-0409-2025
Product
FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25
- Affected lot / code info
- Lot AC-016878, exp date 6/16/2025
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Apollo Care, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3801 Mojave Ct Ste 101, N/A, Columbia, Missouri 65202-4042
Distribution
- Quantity
- 440 bags
- Distribution pattern
- MO
Timeline
- Recall initiated
- 2025-04-15
- FDA classified
- 2025-05-06
- Posted by FDA
- 2025-05-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0409-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.