Recalls / Class II
Class IID-0647-2023
Product
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25
- Affected lot / code info
- Lot #: AC-016633, Exp. Date 05/24/2023; AC-016651, Exp. Date 07/22/2023
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Apollo Care, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3801 Mojave Ct Ste 101, N/A, Columbia, Missouri 65202-4042
Distribution
- Quantity
- 646 bags
- Distribution pattern
- Missouri only
Timeline
- Recall initiated
- 2023-05-02
- FDA classified
- 2023-05-18
- Posted by FDA
- 2023-05-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0647-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.