Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.
673 recalls in this category, newest first.
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Lack of sterility assurance.
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Labeling: Incorrect or missing package insert.
Labeling: Incorrect or missing package insert.
Labeling: Incorrect or missing package insert.
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Lack of sterility assurance.
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
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
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Lack of Processing Controls:
Lack of Processing Controls:
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