🍔 Food 💊 Drugs 🏥 Medical Devices
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05 Class II

Reason: CGMP Deviations:

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