Agency classClass IIOur severity:Severe FDA (Drugs)·D-0748-2021·Announced 2021-08-25

Adenosine Injection Recalled for Lack of Sterility Assurance

Teva Pharmaceuticals USA is recalling Adenosine Injection (60 mg/20 mL vials) nationwide due to lack of assurance of sterility, which could pose a serious health risk if the product is not sterile.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical product with a sterility defect. Injectable products administered intravenously carry inherent risk of serious infection if contaminated, meeting the criteria for a Severe rating even without reported illnesses, because the hazard directly threatens patient safety in a high-risk route of administration.

Plain-English summary

Teva Pharmaceuticals USA is recalling Adenosine Injection, USP, 60 mg/20 mL (3 mg/mL) single-dose vials (NDC 16714-180-01) nationwide, including Puerto Rico. Lot #100022401 with expiration date 04/2023 is affected. Approximately 20,800 vials were distributed.

The recall was initiated because the manufacturer cannot assure that the product meets sterility requirements. Adenosine Injection is administered intravenously to patients; use of a non-sterile injectable product could result in serious infection or other adverse health consequences.

Healthcare providers, pharmacists, and patients should discontinue use of affected vials. Vials should not be dispensed or administered. Customers in possession of affected product should contact Teva Pharmaceuticals USA or their pharmaceutical supplier for instructions on return or destruction. Patients who may have received this product should consult their healthcare provider.

The recalled product

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
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable / Intravenous
Hazard: sterility-defect
infection-risk
contamination
Affected units: 20,800

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 #: 100022401
exp. date 04/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 19 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · sterility defect