FDA-Drug2021-08-25Class II

Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01

Teva Pharmaceuticals USA
Hazard

Lack of Assurance of Sterility

Sold states
Product was distributed Nationwide, including Puerto Rico.
Affected count
20,800 vials
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0748-2021

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