Status
Ongoing
Drug Enforcement D-0409-2025
Lack of Assurance of Sterility
Classification
Class II
Report Date
May 14, 2025
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 440 bags
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- MO
Location & Firm
- Recalling firm
- Apollo Care, LLC
- Address
-
3801 Mojave Ct Ste 101, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0409-2025
- Event ID
- 96754
- Recall initiation date
- April 15, 2025
- Center classification date
- May 6, 2025
- Code info
- Lot AC-016878, exp date 6/16/2025
- More code info
- —