AuroMedics recalls antibiotics due to ‘particulate matter’ in product

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/gustavofrazao)
(Image: Getty/gustavofrazao)
AuroMedics Pharma LLC is voluntarily recalling two lots of injectable antibiotics following customer complaints of “red particulate matter” in the product.

The recall pertains to two lots of Ampicillin and Sulbactam for Injection USP, 3 grams/Single-Dose vial, to the hospital/user level.

According to the announcement from the US Food and Drug Administration (FDA), the recall was 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.”

Per the announcement’s risk statement if a 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.”

The company has not has not received adverse event reports and is arranging for the return and replacement of the recalled product.

The affected Ampicillin and Sulbactam for Injection lots being recalled are AS0317041-A, Exp. Aug 2019, and AS0317035-A, Exp. Aug 2019. 

Related news

Show more

Related products

show more

From Candidate to Clinic- European Capabilities

From Candidate to Clinic- European Capabilities

Catalent Pharma Solutions | 22-Oct-2018 | Technical / White Paper

Catalent’s Nottingham, UK facility focuses on early stage development of small molecule drug candidates from the bench to clinic. This facility offers...

Fill Release at the Right Time in the Right Place

Fill Release at the Right Time in the Right Place

Gelita AG | 19-Sep-2018 | Technical / White Paper

From rapid release in the stomach for e.g. analgesics to enteric release for fills with unpleasant aftertaste – GELITA delivers the respective gelatine...

Strategies to Select and Deliver the Right Candidate

Strategies to Select and Deliver the Right Candidate

Catalent Pharma Solutions | 05-Mar-2018 | Technical / White Paper

Does your candidate have what it takes to succeed? Do you have the information needed to make the right decisions about your candidate’s path to the clinic?...

Related suppliers

Follow us

Products

View more