Status
Ongoing
Drug Enforcement D-0487-2023
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Classification
Class II
Report Date
April 5, 2023
Termination Date
—
Product Information
- 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
- Product quantity
- 215 bags
- Reason for recall
- Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- MO
Location & Firm
- Recalling firm
- Apollo Care
- Address
-
3801 Mojave Ct Ste 101, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0487-2023
- Event ID
- 91674
- Recall initiation date
- February 8, 2023
- Center classification date
- March 24, 2023
- Code info
- Lot #: AC-016581
- More code info
- —