GOLD STAR DISTRIBUTION TYLENOL a) 500 MG., 2'S DISPLAY, 50CT recall — FDA D-0277-2026
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
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754 detailed records are currently available in this category.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred…
Presence of Particulate Matter: Hair was found in a prefilled syringe
Presence of Particulate Matter: Hair was found in a prefilled syringe
Presence of particulate matter: potential presence of metal particulates in the product.
Presence of particulate matter: potential presence of metal particulates in the product.
Subpotent product:out of specification assay results observed during long term stability testing.
Defective container: cracked/broken cartridges
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred…
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