Atovaquone Oral Suspension USP recall — Class I (D-0444-2024) · pharmaranks
Class ITerminated
Atovaquone Oral Suspension USP recall
FDA recall D-0444-2024 · initiated Mar 28, 2024
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Details
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.
Recalling company
AvKARE
Classification
Class I
Status
Terminated
Type
Voluntary: Firm initiated
Distribution
US Nationwide.
Initiated
Mar 28, 2024
FDA report date
Apr 24, 2024
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.