CLASS I Drug recall · Reported 12 Apr 2017 · FDA Enforcement Report
Vancomycin Hydrochloride for Injection, USP, Pharmacy recalled
Hospira Inc., A Pfizer is recalling Vancomycin Hydrochloride for Injection, USP, Pharmacy - Not For Direct Infusion, For, distributed nationwide in the US. The recall was initiated on 24 Jan 2017 and the FDA has classified it as Class I.
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-0638-2017
- FDA event ID
- 76284
- Recalling firm
- Hospira Inc., A Pfizer, Lake Forest, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 24 Jan 2017
- FDA classified
- 5 Apr 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Antibiotics
Timeline
| 24 Jan 2017 | Recall initiated by company | |
| 5 Apr 2017 | Classified by FDA | +71 days |
| 12 Apr 2017 | 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
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Product as listed by the FDA
Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Vancomycin Hydrochloride for Injection, USP, Pharmacy - Not For Direct Infusion, For recalled?
Yes. Hospira Inc., A Pfizer recalled Vancomycin Hydrochloride for Injection, USP, Pharmacy - Not For Direct Infusion, For on 24 Jan 2017. The recall is Class I and its status is Terminated. Recall number D-0638-2017.
Why was it recalled?
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Which lots are affected?
Lot # 591053A, Exp 11/1/2017
Where was it sold?
U.S. 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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Hospira Inc., A Pfizer
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Labetalol Hydrochloride Injection, USP, 100 mg recalledLabetalol Hydrochloride | Hospira Inc. A Pfizer | Foreign Material | Nationwide |
| Drug | CLASS III | Argatroban Injection, 250 mg/ (100 mg/mL) Single-use vial recalled | Hospira Inc., A Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Levophed norepinephrine bitartrate, injection, USP, 4 mg / (1 mg/mL) recalledLevophed | Hospira Inc., A Pfizer | Packaging Defects | Nationwide |
| Drug | CLASS II | METRONIDazole Injection, USP 500 mg (5 mg/mL) recalled | Hospira Inc., A Pfizer | Sterility | Nationwide |
| Drug | CLASS I | Bupivacaine Hydrochloride Inj., USP 5 mg/mL) recalledBupivacaine Hydrochloride | Hospira Inc., A Pfizer | Particulate Matter | Nationwide |
Other Vancomycin recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalledVancomycin Hydrochloride | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin Injection, USP, in 9% Sodium Chloride recalledVancomycin Hydrochloride | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Injection, USP, Sterile powder recalledVancomycin Hydrochloride | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Vancomycin HCl Oral Solution (PF) 125mg recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |