H J Harkins Company Inc dba Pharma Pac recalls Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufa
Recalled August 7, 2019 · FDA recall D-1580-2019 · H J Harkins Company Inc
Hazard
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility. · FDA Class II
Units
97 boxes
Sold at
Distributed in California
Description
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
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
Manufacturer(s)
H J Harkins Company Inc dba Pharma Pac
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →