FDA Drug Recalls

Recalls / Class II

Class IID-0645-2023

Product

VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25

Affected lot / code info
Lot #: AC-016632, Exp. Date 05/24/2023

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
491 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-0645-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls