Neomycin 3 recalled over manufacturing violations

Recall date

July 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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, Manuf…

Recall number

D-1580-2019

FDA classification

Class II

Brand / firm

H J Harkins Company Inc dba Pharma Pac

Sold / distributed

Distributed in California

Why it was recalled

CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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