Agency classClass IIOur severity:Severe FDA (Drugs)·D-0739-2021·Announced 2021-08-25

Teva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance

Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL vials due to lack of assurance of sterility. The product was distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall of an injectable drug where sterility cannot be assured. Norepinephrine is a critical care medication, and loss of sterility assurance in injectable products poses serious risk of infection and patient harm, meeting the rubric criterion for FDA Class II with significant risk of serious injury.

Plain-English summary

Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL in 4 mL single dose vials packaged in 10 vial cartons. The recall affects 34,100 vials distributed nationwide, including Puerto Rico.

The recall is due to lack of assurance of sterility. The affected lots are: Lot #31329045B (expiration 07/2021), Lot #31329077B (expiration 08/2021), and Lot #31329312B (expiration 09/2021). The vial NDC is 0703-1153-01 and the carton NDC is 0703-1153-03.

Patients using this product should contact their healthcare provider or pharmacist. Healthcare providers and patients who have dispensed or used affected vials should contact Teva Pharmaceuticals USA for further guidance.

The recalled product

Product: Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable / Critical Care
Hazard: sterility-assurance
infection-risk
injectable-contamination
Affected units: 34,100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Lot #: 31329045B
exp. date 07/2021
31329077B
exp. date 08/2021
31329312B
exp. date 09/2021

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 19 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

See all →

Moderate
Doxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
Low
Prescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
Moderate
Tretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
Low
Mimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
Moderate
Brinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26

Same hazard · sterility assurance