FDA Drug Recalls

Recalls / Class II

Class IID-0614-2018

Product

Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.

Affected lot / code info
Lot#: AC-015565, Exp. 03/26/2018

Why it was recalled

Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.

Recalling firm

Firm
Apollo Care
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
3801 Mojave Ct Ste 101, Columbia, Missouri 65202-4042

Distribution

Quantity
144 bags
Distribution pattern
Medical Facility in MO

Timeline

Recall initiated
2018-03-07
FDA classified
2018-03-29
Posted by FDA
2018-04-04
Terminated
2018-05-31
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0614-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.