Sagent Pharmaceuticals Recalls Oxacillin for Injection Due to Particulate Matter
Sagent Pharmaceuticals is recalling Oxacillin for Injection due to the presence of small, dark particulate matter in the solution after reconstitution.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is generally remote or unlikely to cause serious adverse health consequences. The hazard involves particulate matter in an injectable solution, which is a quality defect but does not involve high-risk pathogens or reported serious injuries.
Plain-English summary
Sagent Pharmaceuticals Inc is voluntarily recalling 3,990 vials of Oxacillin for Injection, USP, 10 grams per pharmacy bulk package. The product is identified by Lot # OXT515 and has an expiration date of July 2017. The recall is being conducted due to the presence of small, dark particulate matter identified in the solution post-reconstitution.
The recall was initiated after the firm received two product complaints regarding this issue. The affected product is distributed nationwide. The medication is a sterile, nonpyrogenic, preservative-free, buffered solution intended for intravenous use.
Healthcare providers and pharmacies should stop using the affected product and contact Sagent Pharmaceuticals for further instructions. Patients who have received this medication should consult their healthcare provider if they have any concerns.
The recalled product
- 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
- Manufacturer
- Sagent Pharmaceuticals Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 3,990
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: OXT515
- Exp. July 2017
Distribution
Distributed nationwide across the United States.
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