Multi-event March 2018 FDA Recall Drug by Apollo Care

This Multi-event Class II drug recall was voluntarily initiated by Apollo Care on March 7, 2018 for the product Drug. The FDA reported the reason for recall as stability data does not support expiry. The product was distributed in Medical Facility in MO and the recall is currently terminated.

Reported Recall Events

D-0615-2018 TERMINATED D-0614-2018 TERMINATED

Recall Number: D-0615-2018

Reason for Recall
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Initiated
03-07-2018
Reported
04-04-2018
Quantity
96 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79517
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apollo Care
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Medical Facility in MO
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-31-2018
Product Description About Product Description
Full technical description of the product.
Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.

Batch or Lot Expiration Information

Lot# : AC-015569, Exp. 03/26/2018

Recall Number: D-0614-2018

Reason for Recall
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Initiated
03-07-2018
Reported
04-04-2018
Quantity
144 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79517
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apollo Care
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Medical Facility in MO
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-31-2018
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : AC-015565, Exp. 03/26/2018