Class I

Drug Recall: 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 · March 28, 2024

Reason for Recall

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

Distribution

US Nationwide.

States Affected

NATIONWIDE

Quantity Affected

153 cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0444-2024

Status: terminated

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