Nationwide Recall of Popular Antifungal Drug Issued - MedWaste Management Nationwide Recall of Popular Antifungal Drug Issued - MedWaste Management

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Nationwide Recall of Popular Antifungal Drug Issued

Camber Pharmaceuticals, Inc has issued a nationwide recall of their oral suspension of Atovaquone (a generic drug commonly substituted for Mepron) due to possible contamination with Bacillus Cereus, a dangerous bacteria. Atovaquone is commonly subscribed to treat PCP (Pneumocystis Pneumonia), a fungal infection of lungs caused by Pneumocystis Jirovecii, in patients who are unable to be treated with first line therapies such as Trimethoprim-Sulfamethoxazole (a generic medication commonly substituted for Bactrim or Septra). As of the writing of this notice, no adverse events have been reported.

SUMMARY

Date of Recall:

Announced: March 13, 2023

Public Notification: March 31, 2023

Name(s) of Drug:

Atovaquone

Company Name:

Chamber Pharmaceuticals, Inc.

Drug Indication:

PCP (Pneumocystis Pneumonia)

Fungal Infections

Product Description

The oral solution is by prescription only and is packaged in standard white bottles that hold 210 mL of liquid.

Reason for Recall

The drug could possibly be contaminated with Bacillus Cereus, a bacteria that can cause deadly infections including endocarditis (inflammation of the lining of the heart) and necrotizing soft tissue infections.

Impacts

Consumers who have received an effected batch of the medication and who continue to utilize it may experience symptoms such as:

  • Vomiting
  • Diarrhea
  • Fever
  • Chills
  • Sweats
  • Weakness
  • Fatigue
  • Aches & Pains in Muscles/Joints
  • Shortness of Breath with Activity
  • Swelling of Feet, Legs or Abdomen
  • Skin Infections that become increasingly painful or hot or begin to drain a grey liquid.

Lot information

Consumers should locate the bottle in which the medication comes to compare NDC and lot numbers as well as expiration dates with the chart below. If you find your NDC number, lot number and expiration date on the chart below, your medication is affected by the recall and you will need to take additional steps in order to ensure that your health is not affected and to take part in recall procedures.

Product Description NDC UPC Lot Number Expiration Date
Atovaquone Oral Suspension, 750mg/5mL 31722-629-21 331722629218 E220182 12/2023

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

If you find that your lot of medication is part of this recall, do the following:

  1. Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
  2. Continue to monitor your health for any adverse symptoms over the next week and notify your physician if any concerns are noted.
  3. Consumers should contact Inmar by telephone at 1-877-597-0878. They are available Mon-Fri from 9:00am to 5:00pm (EST). You can also contact them via email at rxrecalls@inmar.com.
  4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  5. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and remove stock that is affected by the recall immediately.
  2. Contact Inmar by telephone at 1-877-597-0878 or you can utilize rxrecalls@inmar.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
  3. Notify affected consumers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock that is affected by the recall immediately.
  2. Contact Inmar by telephone at 1-877-597-0878 or you can utilize rxrecalls@inmar.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and/or assistance with disposing of the recalled medication.

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