Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials…
Reason Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
5 FDA recalls mention Stannous. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Stannous.
Reason Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Reason Subpotent Drug
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Reason Presence of Foreign Substance: possibility of the presence of metal in the product.
Reason Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
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