FDA recall D-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.

Reason for recall

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

Distribution

Medical Facility in MO

Key facts

Status

Terminated

Initiation date

2018-03-07

Report date

2018-04-04

Termination date

2018-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbia, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0614-2018