March 2024 FDA Recall Drug by Avkare
D-0444-2024 - Microbial contamination of a non-sterile product

This Class I drug recall was voluntarily initiated by Avkare on March 28, 2024 for the product Drug. The FDA reported the reason for recall as microbial contamination of a non-sterile product. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0444-2024

Reason for Recall
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Initiated
03-28-2024
Reported
04-24-2024
Quantity
153 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94329
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AvKARE
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.
US Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-23-2024
Product Description About Product Description
Full technical description of the product.
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.

Batch or Lot Expiration Information

Lot# Lot: AW0221A Exp. 08/30/2025