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

FDA recall notice · announced October 23, 2024 · Bionpharma

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Reason for recall

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

Notes

Distribution: Nationwide in the U.S.A.
Lot/code information: Lot # 2310083, Exp. 09/30/2025
Quantity: 1,980 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.