Class II · Moderate risk
Oxacillin for Injection
Lack of Assurance of Sterility
Oxacillin for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
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
Affected NDC
25021-0163-69
Compare with the code on your package — it is the most precise check available.
Drug: Oxacillin
- Recalling firm
- Sagent Pharmaceuticals Inc
- NDC code
- 25021-163-69
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1450-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Oxacillin recalls
See all
Class II · Moderate risk
Oxacillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Oxacillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag
Lack of Assurance of Sterility
Other recalls by Sagent Pharmaceuticals Inc
All 2016 recalls
Class III · Low risk
Busulfan Injection
Failed Impurities/Degradation Specifications
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension
Presence of Particulate Matter: Potential for black particulates in the drug product.
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