D-0409-2025 Class II Ongoing
FDA drug recall D-0409-2025 was initiated by Apollo Care, LLC on Apr 15, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 440 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- May 14, 2025
- Initiation Date
- Apr 15, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 440 bags
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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
MO
Code Information
Lot AC-016878, exp date 6/16/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0409-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026