CLASS II Drug recall · Reported 27 Sep 2017 · FDA Enforcement Report
Levophed (norepinephrine bitartrate) injection, USP, 4 mg recalled
Pfizer is recalling Levophed (norepinephrine bitartrate) injection, USP, 4 mg/ (1mg/mL) Fill in Single dose, distributed nationwide in the US. The recall was initiated on 22 Aug 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-1168-2017
- FDA event ID
- 77956
- Recalling firm
- Pfizer, New York, NY
- Brand
- Levophed
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Aug 2017
- FDA classified
- 15 Sep 2017
- Reported
- 27 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Allergy Medication
Timeline
| 22 Aug 2017 | Recall initiated by company | |
| 15 Sep 2017 | Classified by FDA | +24 days |
| 27 Sep 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
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04
Where it was distributed
United States Nationwide (including Puerto Rico) and Singapore
Questions about this recall
Why was it recalled?
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Which lots are affected?
Lot #: 753003A, Exp 9/18; 762153A, 760803A, 761053A , Exp 10/18
Where was it sold?
United States Nationwide (including Puerto Rico) 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.
Other products in this recall event
1 other product · FDA event 77956This product is part of a recall event; the main page for the event is HYDROmorphone HCl Injection, USP, 2 mg/mL Single-use vial recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | HYDROmorphone HCl Injection, USP, 2 mg/mL Single-use vial recalledHydromorphone Hydrochloride | Pfizer | Sterility | Nationwide |
More recalls from Pfizer
All 127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose recalledDopamine Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL) recalled | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-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 |