The United States: Auromedics Pharma LLC issues voluntary nationwide recall of Ampicillin and Sulbactam For Injection USP 3 grams due to the presence of visible particulate matter (English Only)
 
The US Food and Drug Administration (FDA) announces that AuroMedics Pharma LLC is voluntarily recalling two lots of Ampicillin and Sulbactam for Injection USP, 3 grams/Single-Dose vial, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients. 

The affected Ampicillin and Sulbactam for Injection lots being recalled are AS0317041-A, Exp. Aug 2019, and AS0317035-A, Exp. Aug 2019. The product is packaged in a carton containing 10 vials. The product can be identified as a ‘clear vial stoppered with grey rubber stopper and sealed with aluminum seals having a Royal Blue color polypropylene disc’. AuroMedics shipped the entire lot to wholesalers and/or hospitals nationwide in the USA between 19 Oct 2017 through 26 Oct 2017. 

In the event the particulate is administered to the patient, it may result in local site reaction, phlebitis, pulmonary granuloma, occlusion of blood vessels, thromboembolic events and systemic immune response. Patients with vascular disease may be at particular risk of embolic events which could cause permanent impairment or damage to a body structure or function. The risk is reduced by the possibility of detection. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots. 

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm606794.htm 

In Hong Kong, the above product is not a registered pharmaceutical product. 

Ends/Tuesday, May 8, 2018 
Issued at HKT 16:00 

  轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/