February 2023 FDA Recall Drug by Apollo Care
D-0487-2023 - Lack of assurance of sterility

This Class II drug recall was voluntarily initiated by Apollo Care on February 8, 2023 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in MO and the recall is currently ongoing.

Recall Number: D-0487-2023

Reason for Recall
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Initiated
02-08-2023
Reported
04-05-2023
Quantity
215 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91674
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.
Ongoing
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.
MO
Product Description About Product Description
Full technical description of the product.
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25

Batch or Lot Expiration Information

Lot# : AC-016581