Sagent Recalls Oxacillin Injection Due to Particulate Matter
Sagent Pharmaceuticals recalls 3990 vials of Oxacillin for Injection due to dark particulate matter. Check lot OXT515.
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Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
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What happened, in plain English
Sagent Pharmaceuticals is recalling one lot of Oxacillin for Injection, USP, 10 grams per pharmacy bulk package because small, dark particulate matter was found in the solution after reconstitution. The recall covers 3990 vials distributed nationwide. No specific remedy or action steps are currently listed in the record. Read more at govinfonow.com/recall/42589-sagent-recalls-oxacillin-injection-due-to-particulate-matter.
Source Summary by GovInfoNow · govinfonow.com/recall/42589-sagent-recalls-oxacillin-injection-due-to-particulate-matter · Updated October 9, 2026 · FDA enforcement record: FDA #D-1450-2016
Cite this page
“Sagent Recalls Oxacillin Injection Due to Particulate Matter.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42589-sagent-recalls-oxacillin-injection-due-to-particulate-matter. Based on FDA recall #D-1450-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1450-2016%22&limit=1).
Why it’s dangerous
The presence of small, dark particulate matter in the solution post-reconstitution poses a potential health risk if injected into a patient. Foreign particles in an IV drug can cause serious complications such as embolisms or infection.
Who’s affected
Healthcare facilities and pharmacies that purchased this specific pharmacy bulk package of Oxacillin for Injection between the manufacturing date and July 2017. Patients receiving intravenous infusions from these vials are at risk of exposure to particulate matter.
How to tell if you have this one
Look for Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free. The specific lot number is OXT515 with an expiration date of July 2017. The NDC is 25021-163-69.
- Brand
Sagent Pharmaceuticals- Category
Drug
What to do — step by step
Check Inventory
Verify if you have vials of Oxacillin for Injection, USP, 10 grams per pharmacy bulk package with lot number OXT515 and expiration date July 2017.
Monitor Updates
Since no remedy is stated in the record, contact Sagent Pharmaceuticals or your supplier for further instructions on how to handle these vials.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for the recalled product?
The National Drug Code (NDC) is 25021-163-69.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1450-2016 (June 13, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1450-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.