Sagent Pharmaceuticals Inc recalls Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preserv…

Recall date

June 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1450-2016

FDA classification

Class II

Brand / firm

Sagent Pharmaceuticals Inc

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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