CLASS II Drug recall · Reported 21 Jun 2017 · FDA Enforcement Report
Levophed norepinephrine bitartrate, injection, USP, 4 mg / (1 mg/mL) recalled
Hospira Inc. A Pfizer is recalling Levophed norepinephrine bitartrate, injection, USP, 4 mg / (1 mg/mL), distributed nationwide in the US. The recall was initiated on 18 May 2017 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-0898-2017
- FDA event ID
- 77288
- Recalling firm
- Hospira Inc. A Pfizer, Lake Forest, IL
- Brand
- Levophed
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 May 2017
- FDA classified
- 9 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Allergy Medication
Timeline
| 18 May 2017 | Recall initiated by company | |
| 9 Jun 2017 | Classified by FDA | +22 days |
| 21 Jun 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04
Where it was distributed
Nationwide, Canada and Singapore
Questions about this recall
Why was it recalled?
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Which lots are affected?
720503A, 720603A (Canada only)
Where was it sold?
Nationwide, Canada and Singapore
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.
More recalls from Hospira Inc. A Pfizer
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Labetalol Hydrochloride Injection, USP, 100 mg recalled | 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 | Potency & Assay | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Injection, USP, Pharmacy recalled | Hospira Inc. A Pfizer | Particulate Matter | 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 (2.5 mg/mL) recalledBupivacaine Hydrochloride | Hospira Inc. A Pfizer | Particulate Matter | Nationwide |
Other Norepinephrine Bitartrate recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | norepinephrine Bitartrate,16mg per 0.9% Sodium Chloride recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | norepinephrine Bitartrate, 32mg per 0.9% Sodium Chloride recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg recalledNorepinephrine Bitartrate | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS III | Norepinephrine Bitartrate Injection, USP, 4 mg/* recalledNorepinephrine Bitartrate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |