One lot may have experienced temperature excursions during shipment.
Product failure could cause a potential delay in controlling axilla hemorrhage.
Defect could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately.
The labeled expiration date is longer than the known stability of the product.
Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system.
FDA approves label changes after review of a five year safety study.
Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride.
UPDATED 09/16/2014. One AC/DC power adapter production lot added to recall. The casing on some AC/DC power adapters may become loose and separate, resulting in a potential for electric shock.
Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response.
Compromised sterility of a product may lead to risk for infection
Compromised sterility of a compounded preparation may lead to risk for infection.
Using these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer.