Drug 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
D-0487-2023
Product summary
- Firm
- Apollo Care
- Event
- Event 91674
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 215 bags
- Official record key
drug-enforcement:D-0487-2023
Official wording
Reason: Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Code information: Lot #: AC-016581
Distribution pattern: MO
Derived failure modes
-
Microbial contamination
microbial growth
-
Sterility assurance
Lack of assurance of sterility