Product: Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01
Reason for recall: CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Recall initiated: 20190712
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated