Drug 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
D-0409-2025
Product summary
- Firm
- Apollo Care, LLC
- Event
- Event 96754
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 440 bags
- Official record key
drug-enforcement:D-0409-2025
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot AC-016878, exp date 6/16/2025
Distribution pattern: MO
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility