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Class I Recall: Injectable Antibiotic

February 16, 2018

Aurobindo Pharma Ltd. is recalling ampicillin and sulbactam for injection, 1.5-gram vial sterile dry powder for injection, 10 vials per carton (NDC 55150-116-20), because a customer found glass in a vial. The recall was announced in the February 14, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The FDA has designated the recall Class I, signaling use of the affected product could result in serious injury or death.

The recall spans 53,040 vials from lot AF0117001-A. No product expiration date was provided in the enforcement report, but the FDA reported the vials were distributed by AuroMedics Pharma throughout the United States.

Aurobindo Pharma voluntarily initiated the recall January 1, 2018. The FDA designated it class I February 8, 2018.

Ampicillin and sulbactam for injection is used to treat certain bacterial infections. Ampicillin is a penicillin-like antibiotic that stops bacteria growth, and sulbactam is a beta-lactamase inhibitor that prevents bacteria from destroying ampicillin.

Jolynn Tumolo

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