Recalls / Class II
Class IID-0748-2021
Product
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
- Affected lot / code info
- Lot #: 100022401, exp. date 04/2023
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 20,800 vials
- Distribution pattern
- Product was distributed Nationwide, including Puerto Rico.
Timeline
- Recall initiated
- 2021-07-29
- FDA classified
- 2021-08-16
- Posted by FDA
- 2021-08-25
- Terminated
- 2024-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0748-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.