FDAHealthSeptember 17, 2024
Bionpharma Inc. — Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
⚠️ Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 17, 2024
Nationwide in the U.S.A.
What's affected?
- 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.
- Brand
- ATOVAQUONE
- UPC
- 0369452252871
- Lot code
- 2310083
Additional details
Lot # 2310083, Exp. 09/30/2025
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 1,980 bottles.
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