Aurobindo Pharma Ltd. recalls Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed b…

Recall date

January 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0339-2018

FDA classification

Class I

Brand / firm

Aurobindo Pharma Ltd.

Sold / distributed

distributed nationwide in the USA

Why it was recalled

Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20