Reported May 23, 2018 · Terminated

Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC…

Pharmalucence, 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: Pharmalucence, Inc. · 29 Dunham Rd · Billerica, MA · 01821-5729

Is this the product you have?

  • Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2
  • Manufactured byPharmalucence, Inc., Billerica, MA 01821
Lot codes and dates
  • Part Number MEM05 and MEB30 both with expiry date 12/2018
Amount recalled
157 units (5 count) and 464 units (30 count)

Where it was sold

  • Nationwide

Why it was recalled

Failed Stability Specifications

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 Oct 31, 2018 · Data as of Sep 19, 7:18 PM UTC

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