Class I · High risk
Atovaquone Oral Suspension USP
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Atovaquone Oral Suspension
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What 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.
Affected NDC
69452-0252-87
Compare with the code on your package — it is the most precise check available.
Drug: Atovaquone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Atovaquone NDC 69452-0252 |
750 mg/5mL | Suspension Oral |
Bionpharma Inc. | Rx |
- Recalling firm
- Bionpharma Inc.
- NDC code
- 69452-252-87
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Sep 17, 2024 · FDA notice with lot numbers
- FDA recall number
- D-0012-2025 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Atovaquone recalls
See all
Class I · High risk
Atovaquone Oral Suspension USP
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class II · Moderate risk
All Malarone
Lack of Processing Controls
Class II · Moderate risk
Atovaquone active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other recalls by Bionpharma Inc.
All 2024 recalls
Class III · Low risk
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Divalproex Sodium Delayed-Release Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Clobazam Oral Suspension
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
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