Greco Sidari SOFINA 21202 MASTRO CAPOCOLLC 4 - 6LB SUPC/ITEM # 199694 recall — FDA F-0844-2024
The food was not held at an appropriate temperature. The holding temperature could affect spoilage and potentially support pathogen growth.
Complete FDA and NHTSA recall records dated in February 2024.
These records include useful source details for the selected month.
The food was not held at an appropriate temperature. The holding temperature could affect spoilage and potentially support pathogen growth.
Foreign manufacturer of recalled product listed on IA #99-37 due to having no filed scheduled process.
The food was not held at an appropriate temperature. The holding temperature could affect spoilage and potentially support pathogen growth.
The food was not held at an appropriate temperature. The holding temperature could affect spoilage and potentially support pathogen growth.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were…
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Non-Sterility
Non-Sterility
Non-Sterility
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Non-Sterility
Non-Sterility
Non-Sterility
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Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.