Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.
673 recalls in this category, newest first.
Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
Subpotent and Presence of Particulates .
Subpotent Drug
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Subpotent
Labeling: Missing instructions for use insert
Labeling: Incorrect or Missing Lot and/or Exp Date
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
CGMP Deviations
Lack of Assurance of Sterility
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack Of Processing Controls
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.
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