FDA recall D-0339-2018

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

Reason for recall

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

Distribution

distributed nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-01-02

Report date

2018-02-14

Termination date

2019-09-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hyderabad, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0339-2018