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 ReportsSummary written by an AI model from the source text and dated by the source's publication date. Check the original before acting on it. How MedFollow selects and summarizes updates.
Informational only. Not medical advice. Not a substitute for clinical judgment. Always consult current guidelines and your own clinical judgment.
Specialties
More internal medicine updates
- Long-acting injectable noninferior to oral HIV therapy in adherence trialOct 15, 2026
- Ponatinib-Blinatumomab Beats Imatinib-Chemotherapy in Ph-Positive ALL TrialOct 15, 2026
- Isoflurane sedation does not lower mortality in hypoxemic respiratory failureOct 14, 2026
- Trial finds higher mortality with intermittent vs continuous renal-replacement therapyOct 14, 2026
- No Overall Rise in Birth Defects With Early Benzodiazepine UseOct 13, 2026