Aurobindo Pharma Ltd. recalls Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed b
Recalled February 14, 2018 · FDA recall D-0339-2018 · Aurobindo Pharma
Hazard
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial. · FDA Class I
Units
53,040 vials
Sold at
distributed nationwide in the USA
Description
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Product
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
Manufacturer(s)
Aurobindo Pharma Ltd.
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →