PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 25, 2021 Initiated: July 29, 2021 #D-0739-2021

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
34,100 vials
Distribution
Product was distributed Nationwide, including Puerto Rico.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Teva Pharmaceuticals USA. Units affected: 34,100 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on August 25, 2021. Severity: Moderate. Recall number: D-0739-2021.