Reported Nov 15, 2023 · Terminated

Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied…

PAR Sterile Products 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: PAR Sterile Products LLC · 870 Parkdale Rd · Rochester, MI · 48307-1740

Is this the product you have?

  • Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977
  • NDC42023-179-05
Lot codes and dates
  • Lot No343716, Exp
  • Date11/2021
  • Lot No350565, Exp
  • Date07/2022
  • Lot No26921, Exp
  • Date07/2022
  • Lot No36227, Exp
  • Date02/2023

Where it was sold

  • Nationwide

Why it was recalled

Crystallization; identified as Buprenorphine free base

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 Sep 29, 2024 · Data as of Sep 19, 8:05 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.