RecallRadar

FDA Drug recall D-1450-2016

Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only,…

On 2016-08-03 the FDA classified a Class II recall of Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only,… by Sagent Pharmaceuticals, citing presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1450-2016
ClassificationClass II
Statusterminated
Initiated2016-06-13
Published2016-08-03
Last updated2026-09-13 11:51 UTC
CompanySagent Pharmaceuticals
DistributionUS

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

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

Identifiers

code_infoLot #: OXT515, Exp. July 2017

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1450-2016%22

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