Reported Nov 18, 2020 · Terminated

Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx…

Baxter Healthcare Corporation

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: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only
  • Manufactured forBaxter Healthcare Corporation Deerfield, IL 60015 USA
  • Manufactured byBaxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10
Lot codes and dates
    • Lot #: A0B1241
    • Exp 10/2020
    • A0C0091
    • Exp 12/2020
    • A0D0268
    • Exp 02/2022

Where it was sold

  • Nationwide

Why it was recalled

Presence of particulate matter in solution - black and transparent particles

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 May 22, 2023 · Data as of Sep 19, 6:36 PM UTC

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