Quick answers
- What is Alteplase used for?
- The FDA-approved label (Cathflo Activase, Genentech, Inc., January 20, 2026) says: “Cathflo ® Activase ® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Alteplase have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Alteplase?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Alteplase been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started May 20, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Alteplase?
- 1 company lists prescription products of Alteplase in the FDA NDC Directory, including Genentech, Inc..
What Alteplase is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Cathflo ® Activase ® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.
— FDA label: Cathflo Activase, Genentech, Inc., effective January 20, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Cathflo Activase |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| alteplase 2.2 mg/2 mL injection, powder, lyophilized, for solution | Brand: Cathflo Activase | $186.38 per unit |
NADAC list of November 4, 2026; these prices took effect on January 1, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Genentech, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA103172 ACTIVASE, CATHFLO ACTIVASE | Genentech | November 13, 1987 | 11, latest September 1, 2022 2022: Labeling · 2020: Labeling · 2018: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 20, 2024 · Class II · Terminated · D-0509-2024
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64 — Genentech, Inc.
-
March 15, 2021 · Class II · Terminated · D-0476-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| SPL set ID of the quoted label | 91ecdef2-95ff-42dd-a31c-c8a09cab3ad9 |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | BLA103172 |
| Active ingredients (FDA) | ALTEPLASE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cathflo Activase, Genentech, Inc., effective January 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →