Reported Aug 25, 2021 · Terminated

Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose…

Teva Pharmaceuticals USA

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: Teva Pharmaceuticals USA · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120

Is this the product you have?

  • Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
Lot codes and dates
    • Lot #: a) 31327056B
    • exp. date 03/2022
    • 31328547B
    • exp. date 01/2023
    • b) 31327066B
    • exp. date 03/2022
Amount recalled
16,226 vials

This recall covers 19 products

The agency filed one notice per product. You are reading one of them; the other 18 are below.

6 more are in the archive.

Where it was sold

  • Nationwide
  • PR

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 Jun 4, 2024 · Data as of Sep 19, 8:04 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.