Recalls of ophthalmic solutions and eye drops - a category hit by widely reported contamination recalls.
662 recalls in this category, newest first.
Reason Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Reason Non-Sterility
Reason LABELING: LABEL MIX-UP
Reason LABELING: LABEL MIX-UP
Reason Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Reason Failed Impurities/Degradation Specifications
Reason Lack of Sterility Assurance
Reason Lack of Sterility Assurance
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Reason Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Reason Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Reason Temperature abuse: Products exposed to improper temperature above drug label specifications.
Reason Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Reason Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Reason Defective container; yellow colored spike from cap lodged in the nozzle
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Reason Failed Release Testing: Out of specification for particulate matter test.
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current…
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current…
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current…
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current…
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