Summary

Company announcement date:
FDA Publication Date:
Type of product:
Medications
Reason for announcement:

Description of the reason for the recall

Presence of particles

Company Name:
AuroMedics Pharma LLC
Brand:
Product Description:

Product Description

Polymyxin B for Injection USP, 500,000 units/vial


company announcement

FOR IMMEDIATE RELEASE – January 26, 2022 – East Windsor, New Jersey, AuroMedics Pharma LLC has initiated a voluntary recall of lot number CPB200013 of Polymyxin B for Injection USP, 500,000 units/vial, to consumers in the United States market due to a complaint about the presence of particles, identified as a hair discovered in a vial of this batch.

Risk statement: The administration of an intravenous product containing hair, even with the use of a filter, could cause the patient serious hypersensitivity reactions which could be life-threatening. To date, AuroMedics Pharma LLC has not received any reports of identifiable adverse events or safety issues attributed to product consumed from this lot.

Polymyxin B for Injection USP is a sterile white lyophilized cake or powder suitable for the preparation of sterile solutions for intramuscular, intravenous, intrathecal or ophthalmic use indicated for the treatment of infections of the urinary tract, meninges (membranes that protect the brain and spinal cord) and blood circulation caused by susceptible strains of bacteria. It is packaged in a carton containing vials for parenteral or ophthalmic administration, NDC 55150-234-10. The affected lot of Polymyxin B for Injection being recalled is CPB200013 with an expiration date of 09/2022. AuroMedics shipped the entire batch to wholesalers nationwide from March 19, 2021 to June 14, 2021.

The product label is as shown below:

AuroMedics Pharma LLC is notifying its distributors through recall letters and arranging for the return/replacement of all recalled products. Consumers/distributors/retailers who possess the recalled product lot should immediately stop using it and return to the place of purchase/contact their physician as appropriate.

Consumers with medical questions regarding this recall or to report an adverse event may contact AuroMedics Pharma LLC, 8:00 a.m. to 5:00 p.m. MF EST at:

Consumers should contact their doctor or health care provider if they have experienced any problems that may be related to taking or using this pharmaceutical product.

If you have general questions regarding the return of this product, please contact Qualanex at 1-888-280-2046 or email [email protected] (live calls received 7:00 a.m. to 4:00 p.m. MF CST).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch adverse event reporting program either online, by regular mail, or by fax.

  • Complete and submit the report online
  • Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a reporting form, then complete and return it to the address on the pre-addressed form, or submit it by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the United States Food and Drug Administration.


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