🍔 Food 💊 Drugs 🏥 Medical Devices
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
View Details
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