FDA-Drug2021-08-25Class II

Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11

Teva Pharmaceuticals USA
Hazard

Lack of Assurance of Sterility

Sold states
Product was distributed Nationwide, including Puerto Rico.
Affected count
2,091 vials
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0734-2021

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