Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.
662 recalls in this category, newest first.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Subpotent
Reason Labeling: Missing instructions for use insert
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Reason Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Reason CGMP Deviations
Reason Lack of Assurance of Sterility
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Reason Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Lack Of Processing Controls
Reason 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…
Reason 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…
Reason 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…
Reason Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Reason Lack of sterility assurance.
Reason Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Reason Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Reason Labeling: Incorrect or missing package insert.
Reason Labeling: Incorrect or missing package insert.
Reason Labeling: Incorrect or missing package insert.
Reason Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Reason Lack of sterility assurance.
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