D-0636-2023 Class II Ongoing
FDA drug recall D-0636-2023 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: 2040 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- May 24, 2023
- Initiation Date
- May 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2040 bags
Product Description
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Missouri only
Code Information
Lot#: AC-016629, Exp. Date 05/13/2023; AC-016646, Exp. Date 06/24/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0636-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026