FDA recall D-1450-2016

Product

Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69

Reason for recall

Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-06-13

Report date

2016-08-03

Termination date

2017-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1450-2016