The recall covers all lots and expiration dates of Cortaid Creams.
This includes Cortaid 12-hour Advanced Anti-Itch Cream, sold in 1.5-ounce tubes; Cortaid Maximum Strength Cream, sold in 1-ounce tubes; and Cortaid Intensive Therapy Cooling Spray (2-ounces). Anyone with these products should return them to the store for a full refund.
Pseudomonas aeruginosa is a common bacteria that can cause pseudomonas infection. Most pseudomonas infections occur in hospitalized patients and/or with compromised or weakened immune systems. An estimated 51,000 healthcare-associated P. aeruginosa infections occur in the United States each year. More than 6,000 (13%) of these are multidrug-resistant, with roughly 400 deaths per year attributed to these infections.
Multidrug-resistant Pseudomonas was given a threat level of serious threat in the CDC AR Threat report.
Healthy people can also develop mild illness with Pseudomonas aeruginosa, especially when exposed through water. Ear infections are a common reaction, especially in children. Exposure to the bacterial through inadequately chlorinated hot tubs or swimming pools can result in generalized skin rashes as well. Patients using infected extended-wear contact lenses have reported eye infections.
To the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall so far.
Cortaid is not the only product that Product Quest is recalling for Pseudomonas aeruginosa contamination. All its nasal products and baby oral gels are suspect to the bacteria and are being recalled. In August, Product Quest Manufacturing recalled nasal sprays sold as name brands and as the house brands for Walgreens, CVS, Meijer, Dollar General, Rexall, Family Dollar, Rite-Aid and Harmon.
On September 17, Valeant Pharmaceuticals announced the recall of all Cortaid creams, and on September 24, they recalled Ocean Saline Nasal Spray.
MediNatura recalled 19 lots of two nasal sprays, a throat spray and a cough syrup for a “possible microbial contamination” in the water-based products. Clearlife Nasal Spray, Reboost Nasal Spray, Reboost Throat Spray, each in 20 ml bottles, and 125 ml bottles of Reboost Cough Syrup are involved in the recall.
“Administration or use of drug products with microbial contamination, could potentially result in increased infections that may require medical intervention,” MediNatura’s website recall notice says.
To date, the company has not received any reports of illness or injury.
KIngBio has recalled Baby Teething Liquids for microbial contamination, and many other water-based products, due to the same bacteria in their water.
Product Quest is notifying its customers by oral and written communication and is arranging for return/replacement etc. of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to the place of purchase or discard the product.
Consumers with questions regarding this recall can contact Product Quest Manufacturing LLC at (386) 239-8787, Monday through Friday from 8 am to 4 pm, EST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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