October 2021 FDA Recall Drug by Apollo Care
D-0277-2022 - Crystallization

This Class II drug recall was voluntarily initiated by Apollo Care on October 28, 2021 for the product Drug. The FDA reported the reason for recall as crystallization. The product was distributed in MO and the recall is currently terminated.

Recall Number: D-0277-2022

Reason for Recall
Crystallization: Product appears to be turbid.
Initiated
10-28-2021
Reported
12-15-2021
Quantity
225 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89011
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MO
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-28-2022
Product Description About Product Description
Full technical description of the product.
VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-254-25

Batch or Lot Expiration Information

Lot# : AC-016402, Exp 2/12/2022