Reported Aug 15, 2018 · Terminated
Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (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 Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only
- Manufactured byPharmalucence, Inc., Billerica, MA 01821
- Lot codes and dates
- Lot 4223
- Amount recalled
- 95 kits
Where it was sold
- Nationwide
Why it was recalled
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
This product could cause temporary or reversible health problems — stop using it.
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