CLASS II Drug recall · Reported 17 Dec 2014 · FDA Enforcement Report
Midazolam Hydrochloride Injection, 5 mg/, C-iv recalled
Fresenius Kabi USA is recalling Midazolam Hydrochloride Injection, 5 mg/, C-iv, For IM or IV Use Vials, distributed nationwide in the US. The recall was initiated on 27 Sep 2012 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-0295-2015
- FDA event ID
- 63451
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Brand
- Midazolam
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Sep 2012
- FDA classified
- 10 Dec 2014
- Reported
- 17 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Sep 2012 | Recall initiated by company | |
| 10 Dec 2014 | Classified by FDA | +804 days |
| 17 Dec 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Product as listed by the FDA
MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.
Where it was distributed
U.S. Nationwide Including Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Which lots are affected?
Lot 6003827, Exp. Date 04/2015
Where was it sold?
U.S. Nationwide Including 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 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.
Other products in this recall event
2 other products · FDA event 63451This product is part of a recall event; the main page for the event is Cyanocobalamin Injection, USP, 1000 mcg/mL recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cyanocobalamin Injection, USP, 1000 mcg/mL recalledCyanocobalamin | Fresenius Kabi USA | Particulate Matter | Nationwide | |
| CLASS II | Ondansetron Injection, USP, 4 mg/ (2 mg/mL) recalledOndansetron | Fresenius Kabi USA | Particulate Matter | Nationwide |
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 (0.2 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 Midazolam recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Midazolam HCl 100 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS I | Midazolam in 0.8% Sodium Chloride Injection 100 mg recalled | Exela Pharma Sciences | Particulate Matter | Nationwide |
| Drug | CLASS II | midazolam in dextrose 5%, 50 mg/, (1 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | midazolam in dextrose 5%, 50 mg /, (1 mg/mL) Syringe recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |