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
Reported: August 3, 2016 Initiated: June 13, 2016 #D-1450-2016
Product Description
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 for Recall
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Details
- Recalling Firm
- Sagent Pharmaceuticals Inc
- Units Affected
- 3990 vials
- Distribution
- Nationwide
- Location
- Schaumburg, IL
Frequently Asked Questions
What product 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. Recalled by Sagent Pharmaceuticals Inc. Units affected: 3990 vials.
Why was this product recalled? ▼
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 3, 2016. Severity: Moderate. Recall number: D-1450-2016.
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