FDA-Drug2018-02-14Class I
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
Aurobindo Pharma Ltd.
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.
Sold states
distributed nationwide in the USA
Affected count
53,040 vials
Manufactured in
Unit Xii, Lactam Formulation Plant, Survey No. 314, Bachupally, Quthbullapur, Hyderabad, N/A, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0339-2018Don't want to check this manually?
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