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
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Affected NDCs
25021-0163-68
25021-0163-99
Compare with the code on your package — it is the most precise check available.
Drug: Oxacillin
- Recalling firm
- Sagent Pharmaceuticals
- NDC code
- 25021-163-99
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0937-2023 · 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.
Other Oxacillin recalls
See all
Class II · Moderate risk
Oxacillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Oxacillin for Injection
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Class II · Moderate risk
Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag
Lack of Assurance of Sterility
Other recalls by Sagent Pharmaceuticals
All 2023 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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