Dexamethasone Sodium Phosphate is an adrenocortical steroid given to treat inflammatory or allergic conditions. Here are just a few examples of the conditions that it is used to treat:
• Bronchial asthma
• Contact and atopic dermatitis
• Allergic rhinitis
• Serum sickness (an allergic reaction to animal products in medicines)
• Drug hypersensitivity reactions
• Stevens-Johnson syndrome
Now the company who makes the drug, American Regent, is recalling three lots of it because they contain particulates or have the potential to form particulates even though they are not yet at their expiration dates.
Having particulates in injectable drugs is dangerous as they can disrupt the blood flow in small blood vessels in the lungs and could also result in an inflammatory response with pain, swelling and possible long-term granuloma formation. A granuloma is a non-cancerous inflammation of the tissue.
The lots recalled are:
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL Single Dose Vials.
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 5 mL Multiple Dose Vials.
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vials.
Medical professionals should not use these lots in any setting, whether that be hospitals, clinics, physician offices or infusion centers.
If you are a medical professional and you have any of the affected lots, you can return them by accessing the recall website and American Regent will credit your account:
Source: Food and Drug Administration Drug Recalls.