
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%)
Lack of Assurance of Sterility
Page 2 of 40 · 1,986 total recalls

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Possible foreign object (thin, soft plastic strands).

Presence of Precipitate: medication was crystallizing and particles floating in the bottle

Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the...

Allergen missing from contains statement: fish

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Moringa Powder ingredient positive for salmonella

No labeling. Undeclared wheat and colors: Yellow#5, Yellow#6.

Lack of Assurance of Sterility

Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product...

Potential E. coli O145:H28 Contamination

Ambient storage of the product may lead to Clostridium botulinum toxin formation.


Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in...

Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in...

Product label allergen "contains" statement does not include anchovy(fish)

Firm's finished product label does not declare the source of marine collagen which was determined to be fish.

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis...

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis...

Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or...

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Presence of Foreign Tablets/Capsules

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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