FDA recall D-0444-2024

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.

Reason for recall

Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.

Distribution

US Nationwide.

Key facts

Status

Terminated

Initiation date

2024-03-28

Report date

2024-04-24

Termination date

2024-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0444-2024