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Recall Observatory FDA recall evidence

Drug product

Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

D-0012-2025

September 17, 2024

Class I

Product summary

Firm
Bionpharma Inc.
Event
Event 95345
Status
Terminated
Classification
Class I
Quantity
1,980 bottles
Official record key
drug-enforcement:D-0012-2025

Official wording

Reason: Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

Code information: Lot # 2310083, Exp. 09/30/2025

Distribution pattern: Nationwide in the U.S.A.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination