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NORTH BERGEN, New Jersey — DermaRite Industries has recalled several of its soaps, cleansers, and additional products due to a microbial contamination called Burkholderia cepecia.
The New Jersey-based medical care and skin care products manufacturer says Burkholderia Cepacia Complex in the recalled products could result in serious and life-threatening infections.
Use of the products by immunocompromised individuals or those attending to them could lead to infection more likely to spread into the blood stream, leading to life-threatening sepsis. Use by healthy individuals with minor skin lesions is more likely to result in local infections.
So far, the company has not received any reports of adverse events related to the recall.
The company has notified its distributors and customers via email, asking them to check their products and to destroy any items mentioned in the recall.
The recalled products were distributed across the United States of America and Puerto Rico.
For specific information including reorder numbers, lot numbers, and expiration dates, see the listings on the FDA website.
The recalled products include:
DermaKleen:
An OTC Healthcare antiseptic lotion soap with Vitamin E, indicated for handwashing to decrease bacteria on the skin.
DermaKleen 1000ml. bag-n-box, 10/case, DermaKleen 800ml. bag-n-box, 12/case
DermaSarra:
An OTC External analgesic indicated for temporary relief of itching associated with minor skin irritations due to: dry skin, insect bites, detergents, sunburn.
DermaSarra 7.5oz, 24/case
KleenFoam:
An OTC Antimicrobial foam soap with Aloe Vera indicated for handwashing to decrease bacteria on the skin after changing diapers, after assisting ill people, or before contact with a person under medical care or treatment.
KleenFoam 1000ml. 6/case
PeriGiene:
An OTC Antiseptic cleanser indicated for use in the perineal area.
PeriGiene 7.5oz., 48/case
Anyone with questions can call 973-569-9000 X104 between 9 a.m. and 5 p.m., Monday through Friday, or email voluntary.action@dermarite.com.
If consumers have experienced any issues that could be related to taking or using the recalled products, they should contact their physician or healthcare provider, and adverse reactions or quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail, or by fax.
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