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  4. Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial
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COMPANY ANNOUNCEMENT

Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial

Summary

Company Announcement Date:
January 09, 2018
FDA Publish Date:
January 10, 2018
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
Presence of Glass Particles in Vial
Company Name:
AuroMedics Pharma LLC
Brand Name:
Brand Name(s)
AuroMedics Pharma LLC
Product Description:
Product Description
Ampicillin and Sulbactam for Injection USP

Company Announcement

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling lot AF0117001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles.

Risk Statement: The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product.

The product Ampicillin and Sulbactam for Injection is used for treatment of infections due to susceptible strains of designated microorganism in skin and skin structure infections, intra- abdominal infections and gynecological infections in adults and for in treatment of skin and skin structure infection in pediatric patient one year and older. The affected Ampicillin and Sulbactam for Injection lot being recalled is AF0117001-A, EXP. December 2018. It is packaged in a carton containing 10 vials, NDC: 55150-116-20. 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 on February 9, 2017.

AuroMedics Pharma LLC is notifying its distributors and customers by recall letters and is arranging for return/replacement etc. of all recalled product. Consumers/distributors/retailers that have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate.

Consumers with questions regarding this recall can contact AuroMedics Customer Service Monday through Friday from 9:00AM to 5:00PM EST at 888-238-7880 Option 1. If you need assistance in returning your product or have questions about the  recall process, contact Inmar at 800-967-5952, Monday through Friday from 8:30 AM to  5:00 PM EST. Consumers should contact their physician or healthcare provider if they have  experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
888-238-7880 Option 1

Product Photos