Reported Sep 2, 2020 · Terminated

Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by:…

Hikma Pharmaceuticals USA Inc.

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: Hikma Pharmaceuticals USA Inc. · 2 Esterbrook Ln · Cherry Hill, NJ · 08003-4002

Is this the product you have?

  • Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only
  • Manufactured byHikma Farmaceutica, Portugal S.A
  • Distributed byHikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc
  • NDC0143-9246-01
Lot codes and dates
    • Lot #s: 2005023.1
    • 2005024.1
    • 2005025.1
    • Exp 02/28/2021
Amount recalled
97,890 vials

Where it was sold

  • Nationwide

Why it was recalled

Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.

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 10, 2021 · Data as of Sep 19, 7:57 PM UTC

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