Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Stability Specifications
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 by: Pharmalucence, Inc., Billerica, MA 01821.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of…
Reason Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Reason Failed Stability Specifications
Reason Failed Stability Specifications
Reason Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
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