PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 25, 2021 Initiated: July 29, 2021 #D-0748-2021

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
20,800 vials
Distribution
Product was distributed Nationwide, including Puerto Rico.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Teva Pharmaceuticals USA. Units affected: 20,800 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-0748-2021.