CGMP/Finished Pharmaceuticals/Adulterated
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Sno Pac Foods of Caledonia, MN, is recalling Del Mar 35 LB Bulk Organic Frozen Spinach and Sno Pac10 oz Organic Frozen Cut Spinach because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious or sometimes fatal infections in young children, fraiCentral Admixture Pharmacy Services Inc. Phoenix, AZ. 483 issued 09/05/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/05/2025
Short Title (70 char) Central Admixture Pharmacy Services Inc. Phoenix, AZ. 483 issued 09/05/2025
FEI Number 3014307835
Firm Name Central Admixture Pharmacy Services Inc
Record Type 483
State AZ
EstabCDER Nitrosamine Impurity Acceptable Intake Limits
Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs); Updated InformationFDA Rationale for Breakpoints Recognition Decision: Azithromycin and Neisseria gonorrhoeae
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Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complicationsBoothwyn Pharmacy LLC – 710247 – 06/09/2025
Unapproved New Animal Drug/Adulterated/Misbranded
