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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