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FDAMarch 28, 2024drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

avkare

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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