FDA-Drug2021-08-25Class II

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

Teva Pharmaceuticals USA
Hazard

Lack of Assurance of Sterility

Sold states
Product was distributed Nationwide, including Puerto Rico.
Affected count
34,100 vials
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0739-2021

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