← FDA ENFORCEMENT
D-0012-2025Class I

Bionpharma Inc.

Recalling firm
Bionpharma Inc.
Product type
Drug
Status
Terminated
Report date
2024-10-23
Distribution
Nationwide in the U.S.A.
Firm state
NJ
Product quantity
1,980 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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

Code / lot info

Lot # 2310083, Exp. 09/30/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.