Product: Polyhexamethylene biguanide 0.02% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Reason for recall: Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Recall initiated: 20140827
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated