Reported Apr 3, 2024 · Terminated

labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd.,…

SCA Pharmaceuticals, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SCA Pharmaceuticals, LLC · 755 Rainbow Rd Ste B · Windsor, CT · 06095-1024

Is this the product you have?

    • labetalol HCl 20 mg/4mL Injection
    • (Concentration=5 mg/mL)
    • 4 mL fill Syringe
    • Rx Only
    • SCA Pharma
    • 755 Rainbow Rd
    • Windsor
    • CT 06095
    • NDC 70004-0700-28
    • Bar Code 70004070028
Lot codes and dates
    • Lot #: 1223047334 Exp 12/23/23
    • 1223048170 Exp 02/01/24
Amount recalled
2,458, syringes

This recall covers 32 products

The agency filed one notice per product. You are reading one of them; the other 31 are below.

19 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 27, 2024 · Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.