D-0487-2023 Class II Ongoing
FDA drug recall D-0487-2023 was initiated by Apollo Care on February 8, 2023 and is designated Class II. Reason for recall: Lack of assurance of sterility: Suspected microbial growth present on external label packaging. The recall status is ongoing. Affected quantity: 215 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- April 5, 2023
- Initiation Date
- February 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 215 bags
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.
Distribution Pattern
MO
Code Information
Lot #: AC-016581