CLASS II Drug recall · Reported 19 Jan 2022 · FDA Enforcement Report

Norepinephrine Bitartrate Injection USP 4 mg recalled

Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection USP 4 mg/ (1 mg/mL) Single-Dose Vials, 10 vials per, distributed in Mississippi, Ohio, Tennessee. The recall was initiated on 31 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 100020800, exp 07/2022

Quantity recalled11,450 vials

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-0371-2022
FDA event ID: 89326
Recalling firm: Teva Pharmaceuticals USA, Parsippany, NJ
Classification: Class II
Status: Terminated
Recall initiated: 31 Dec 2021
FDA classified: 13 Jan 2022
Reported: 19 Jan 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Allergy Medication

Timeline

31 Dec 2021	Recall initiated by company
13 Jan 2022	Classified by FDA	+13 days
19 Jan 2022	Published in enforcement report	+6 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

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

Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.

Where it was distributed

Methylprednisolone, TN Norepinephrine BItartrate - MS, OH

Mississippi Ohio Tennessee

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot # 100020800, exp 07/2022

Where was it sold?

Methylprednisolone, TN Norepinephrine BItartrate - MS, OH

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 89326

This product is part of a recall event; the main page for the event is MethylPREDNISolone Acetate Injectable Suspension recalled.

Reported	Class	Recall	Company	Reason	Where
19 Jan 2022	CLASS II	MethylPREDNISolone Acetate Injectable Suspension recalled	Teva Pharmaceuticals USA	Sterility	MS, OH, TN

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All 280

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Other Norepinephrine Bitartrate recalls

All 21

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026Drug	CLASS II	norepinephrine Bitartrate,16mg per 0.9% Sodium Chloride recalled	Fagron Compounding Services	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	norepinephrine Bitartrate, 32mg per 0.9% Sodium Chloride recalled	Fagron Compounding Services	Sterility	Nationwide
28 Feb 2024Drug	CLASS II	Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg recalledNorepinephrine Bitartrate	Baxter Healthcare	Packaging Defects	Nationwide
19 Apr 2023Drug	CLASS III	Norepinephrine Bitartrate Injection, USP, 4 mg/* recalledNorepinephrine Bitartrate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
8 Mar 2023Drug	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide