Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Ceftriaxone for Injection (Ceftriaxone Sodium)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Missing Label
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01
Affected NDC
0409-7332-01
Compare with the code on your package — it is the most precise check available.
Drug: Ceftriaxone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Ceftriaxone Sodium NDC 00409-7332 |
1 g/1 | Injection, Powder, for Solution Intramuscular|intravenous |
Hospira, Inc | Rx |
- Recalling firm
- Sandoz Inc
- NDC code
- 0409-7332-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0145-2017 · 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 Ceftriaxone recalls
See all
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
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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