Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufa...
FDA Recall #D-0444-2024 — Class I — March 28, 2024
Product Description
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.
Reason for Recall
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Recalling Firm
AvKARE — Pulaski, TN
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
153 cartons
Distribution
US Nationwide.
Code Information
Lot: AW0221A Exp. 08/30/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated