FDA-Drug2019-08-07Class II
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
H J Harkins Company Inc dba Pharma Pac
Hazard
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Sold states
Distributed in California
Affected count
97 boxes
Manufactured in
1400 W Grand Ave Ste F, N/A, Grover Beach, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1580-2019Don't want to check this manually?
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