Recalls / Class II
Class IID-0580-2018
Product
Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-264-25.
- Affected lot / code info
- Lot: AC-015560, Exp 03/14/2018
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
- Type
- Voluntary: Firm initiated
- Address
- 3801 Mojave Ct Ste 101, N/A, Columbia, Missouri 65202-4042
Distribution
- Quantity
- 312 bags
- Distribution pattern
- Medical Facility in MO
Timeline
- Recall initiated
- 2018-02-15
- FDA classified
- 2018-03-06
- Posted by FDA
- 2018-03-14
- Terminated
- 2018-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0580-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.