FDA-Drug2016-08-03Class II

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

Sagent Pharmaceuticals Inc
Hazard

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

Sold states
Nationwide
Affected count
3990 vials
Manufactured in
1901 N Roselle Rd Ste 700, N/A, Schaumburg, IL, United States
Products
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

Official notice

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

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