Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Reported: October 23, 2024 Initiated: September 17, 2024 #D-0012-2025
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.
Reason for Recall
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Details
- Recalling Firm
- Bionpharma Inc.
- Units Affected
- 1,980 bottles
- Distribution
- Nationwide in the U.S.A.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.. Recalled by Bionpharma Inc.. Units affected: 1,980 bottles.
Why was this product recalled? ▼
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 23, 2024. Severity: Critical. Recall number: D-0012-2025.
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