CLASS III Drug recall · Reported 26 Nov 2014 · FDA Enforcement Report
Sterile powder Vancomycin Hydrochloride for Injection recalled
Hospira is recalling Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to in fliptop vial, distributed nationwide in the US. The recall was initiated on 7 Nov 2014 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-0254-2015
- FDA event ID
- 69659
- Recalling firm
- Hospira, Lake Forest, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Nov 2014
- FDA classified
- 19 Nov 2014
- Reported
- 26 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Antibiotics
Timeline
| 7 Nov 2014 | Recall initiated by company | |
| 19 Nov 2014 | Classified by FDA | +12 days |
| 26 Nov 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
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Product as listed by the FDA
Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01.
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Which lots are affected?
Lot# 43-240-DD; Exp. 07/16 Lot# 44-205-DD,44-455-DD,44-460-DD,44-465-DD; Exp. 08/16
Where was it sold?
Nationwide.
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 | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
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| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
Other Vancomycin recalls
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalledVancomycin Hydrochloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vancomycin Injection, USP, in 0.9% Sodium Chloride recalledVancomycin Hydrochloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Vancomycin 1 MG/ Solution for Intraocular Injection Single Dose Vial recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | vancomycin 750 mg/ added to 0.9% Sodium Chloride, (3 mg/mL), IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |