Medications & Supplements/Prescription Drugs

Atovaquone Oral Suspension Recalled for Bacillus Cereus Contamination

Agency Publication Date: May 8, 2023

Summary

Camber Pharmaceuticals Inc. is recalling 1,568 bottles of Atovaquone Oral Suspension USP (750 mg/5 mL). The recall was issued because testing of the repackaged medicine found a contaminant identified as Bacillus cereus. This medication is commonly used to treat or prevent a specific type of pneumonia in patients who cannot tolerate other treatments.

Risk

The presence of Bacillus cereus in a non-sterile product can lead to serious infections, particularly in individuals with weakened immune systems. This can cause severe gastrointestinal distress or more invasive, life-threatening infections.

What You Should Do

This recall affects Atovaquone Oral Suspension USP (750 mg/5 mL) packaged in 210 mL bottles under the Camber Pharmaceuticals brand.
Identify the affected product by checking the label for NDC 31722-629-21 and Lot number E220182 with an expiration date of 12/31/2023.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Atovaquone Oral Suspension USP (210 mL)

Variants: 750 mg/5 mL

UPC Codes:

331722629218

Lot Numbers:

E220182 (Exp. 12/31/2023)

NDC:

31722-629-21

Manufactured for Camber Pharmaceuticals, Inc. by Hetero Labs Limited in India.

Product Images

Image 1 - Container Label, Atovaquone Oral Suspension, USP 750mg/5mL

Image 2 - Carton Label, Atovaquone Oral Suspension, USP 750mg/5mL

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91808

Status: Active

Manufacturer: Camber Pharmaceuticals Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 1568 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Atovaquone Oral Suspension USP (750 mg/5 mL) packaged in 210 mL bottles under the Camber Pharmaceuticals brand.

Identify the affected product by checking the label for NDC 31722-629-21 and Lot number E220182 with an expiration date of 12/31/2023.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for more information.