28-Dec-10 9:00 AM  CST

American Regent Recalls Injection Vials

American Regent has issued a recall for sodium bicarbonate and dexamethasone sodium phosphate injection vials due to the presence of small particles inside some of the vials.

The recalls are specifically for 4 mg/mL, 30 mL multiple-dose injections vials of dexamethasone sodium phosphate, 44.6 mEq/50 mL single-dose injection vials of sodium bicarbonate (USP,  7.5%), and 50 mEq/50 mL single dose injection vials of sodium bicarbonate (USP, 8.4%). Some of the vials within the recalled lots were found to contain tiny clumps of matter or could form tiny clumps before their expiration date. A list of the recalled lot numbers along with their expiration dates is available on American Regent’s website under the News and Events section.

Dexamethasone sodium phosphate is an anti-inflammatory medication used to treat allergic reactions, skin conditions, certain autoimmune diseases and nausea and vomiting associated with some chemotherapy medications. Sodium bicarbonate injections are used primarily to treat metabolic acidosis, a complication of diseases such as diabetes, renal disease, severe anemia and cancer.

American Regent is a division of Luitpold Pharmaceuticals. The recalled injection vials were manufactured by Luitpold and distributed by American Regent. The FDA has also released information about the recalls on its recalls and alerts web page. Wholesalers, hospitals, clinics and other health care facilities who may have received the recalled lots should contact American Regent for more information. Patients who may have experienced an adverse reaction to the recalled medications should report their reactions to American Regent or the FDA MedWatch program.
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For additional information on this article, please contact:
Kristina Michel
(888) 247-8700
Source: NPTANews  

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