Adenosine Injection Vials Recalled for Sterility Assurance Failure
Teva Pharmaceuticals is recalling Adenosine Injection, USP 60mg/20mL vials nationwide due to lack of assurance of sterility. The recall affects 4,249 vials distributed nationwide, including Puerto Rico.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterile injectable drug product with a sterility assurance defect. Although no illnesses or injuries are reported in the source text, the hazard is real and non-theoretical—a sterile injection product without assured sterility presents a direct risk of harm (infection) to patients. Per the rubric, this qualifies as High (score 3).
Plain-English summary
Teva Pharmaceuticals USA Inc. is recalling Adenosine Injection, USP, 60mg/20mL (3 mg/mL) in 20 mL single-dose vials nationwide, including Puerto Rico. The affected product is NDC 0703-8776-01, Lot #100022400 with an expiration date of 04/2023. A total of 4,249 vials have been distributed.
The recall is due to lack of assurance of sterility. Adenosine Injection is a prescription medication administered intravenously for diagnostic purposes, and any sterility defect poses a potential risk to patients.
Patients and healthcare providers in possession of affected vials should stop using the product immediately. Healthcare facilities should quarantine and return the recalled product to Teva Pharmaceuticals USA Inc., Parsippany, NJ 07054, or contact them for return instructions.
The recalled product
- Product
- Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01
- Manufacturer
- Teva Pharmaceuticals USA
- Affected units
- 4,249
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 100022400
- exp. date 04/2023
Distribution
Part of a larger recall action
This product is one of 19 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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