Safety alertSource: FDA Drug Enforcement Reports

Class II recall: American Regent, Inc.: Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged

American Regent, Inc. issued a Class II recall of Atropine Sulfate Injection, USP, 1 mg/mL for intravenous use, packaged in 1 mL and 25x1 mL single-dose vials (NDC 0517-1001-01 and 0517-1001-25). The recall notice states the product was found to be contaminated with particulate matter identified as hair, glass, and/or paraformaldehyde. The affected lots were manufactured by American Regent Inc., Shirley, NY.

Most relevant for: Patients who may have received atropine sulfate injection from the recalled lots or healthcare facilities using the affected product batches for emergency treatment, anesthesia, or other clinical indications requiring intravenous atropine administration.

Read the original at FDA Drug Enforcement Reports

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Informational only. Not medical advice. Not a substitute for clinical judgment. Always consult current guidelines and your own clinical judgment.

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