CLASS III Drug recall · Reported 30 Nov 2016 · FDA Enforcement Report
Ceftriaxone for Injection, USP use Vials recalled by Sandoz
Sandoz is recalling Ceftriaxone for Injection, USP use Vials, distributed in Wisconsin. The recall was initiated on 19 Oct 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0145-2017
- FDA event ID
- 75563
- Recalling firm
- Sandoz, Princeton, NJ
- Brand
- Ceftriaxone Sodium
- Manufacturer
- Hospira, Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Oct 2016
- FDA classified
- 19 Nov 2016
- Reported
- 30 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Antibiotics
Timeline
| 19 Oct 2016 | Recall initiated by company | |
| 19 Nov 2016 | Classified by FDA | +31 days |
| 30 Nov 2016 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Missing Label
Product as listed by the FDA
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
Where it was distributed
WI
Questions about this recall
Why was it recalled?
Labeling: Missing Label
Which lots are affected?
Sandoz - Lot GJ7151(Pfizer- Lot 670028M); Exp. 07/19
Where was it sold?
WI
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Drug | CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
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Other Ceftriaxone recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ceftriaxone for Injection, USP per Pharmacy recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ceftriaxone for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ceftriaxone for Injection, USP 250 mg per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ceftriaxone for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ceftriaxone for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |