Class II · Moderate risk
Oxacillin for Injection
Lack of Assurance of Sterility
Dicloxacillin Sodium Capsules USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
Affected NDC
0781-2258-01
Compare with the code on your package — it is the most precise check available.
Drug: Oxacillin
- Recalling firm
- Sandoz, Inc
- NDC code
- 0781-2258-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1046-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 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 Sandoz, Inc
All 2016 recalls
Class III · Low risk
Focalin XR
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Cyclophosphamide Injection 500 mg/5 mL
cGMP deviations: Temperature excursion during transportation.
Class II · Moderate risk
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Temperature Abuse
Class I · High risk
Buffered Penicillin G Potassium for Injection
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
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