CLASS II Drug recall · Reported 17 Dec 2014 · FDA Enforcement Report
Gentamicin Injection, USP, equivalent to 40 mg/mL recalled
Fresenius Kabi USA is recalling Gentamicin Injection, USP, equivalent to 40 mg/mL, distributed nationwide in the US. The recall was initiated on 12 Nov 2014 and the FDA has classified it as Class II.
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-0290-2015
- FDA event ID
- 69810
- Recalling firm
- Fresenius Kabi USA, Melrose Park, IL
- Brand
- Gentamicin
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Nov 2014
- FDA classified
- 8 Dec 2014
- Reported
- 17 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Nov 2014 | Recall initiated by company | |
| 8 Dec 2014 | Classified by FDA | +26 days |
| 17 Dec 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Vials may be missing stoppers.
Product as listed by the FDA
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Gentamicin Injection, USP, equivalent to 40 mg/mL recalled?
Yes. Fresenius Kabi USA recalled Gentamicin Injection, USP, equivalent to 40 mg/mL on 12 Nov 2014. The recall is Class II and its status is Terminated. Recall number D-0290-2015.
Why was it recalled?
Defective Container: Vials may be missing stoppers.
Which lots are affected?
Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015
Where was it sold?
Nationwide and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
All 94| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per 2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Gentamicin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gentamicin Injection, USP, (Pediatric), 20 mg recalled by Eugia USGentamicin | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Ointment USP 1%, packaged as a) tube recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Injection USP 80 mg/(40 mg/mL as recalled by HospiraGentamicin Sulfate | Hospira | Particulate Matter | Nationwide |