D-0646-2023 Class II Ongoing
FDA drug recall D-0646-2023 was initiated by Apollo Care, LLC on May 2, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 308 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- May 24, 2023
- Initiation Date
- May 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 308 bags
Product Description
FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Missouri only
Code Information
Lot #: AC-016644, Exp. Date 05/08/2023; AC-016659, Exp. Date 09/26/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0646-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026