Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Oasis Medical
Class I - Dangerous
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class I - Dangerous
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Falied pH specification
Failed pH specification
Class I - Dangerous
Labeling: Missing Label; The label on the immediate bottle is missing.