FDA-Drug2024-04-24Class I

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.

AvKARE
Hazard

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

Sold states
US Nationwide.
Affected count
153 cartons
Manufactured in
615 N 1st St, Pulaski, TN, United States
Products
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.

Official notice

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

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