🍔 Food 💊 Drugs 🏥 Medical Devices
Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs Class II

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. 20230426 Ongoing
Distributed: Nationwide in the USA and Puerto Rico
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Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs Class II

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. 20230426 Ongoing
Distributed: Nationwide in the USA and Puerto Rico
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Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Class II

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. 20230426 Ongoing
Distributed: Nationwide in the USA and Puerto Rico
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Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs Class II

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. 20230426 Ongoing
Distributed: Nationwide in the USA and Puerto Rico
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DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Class II

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. 20230426 Ongoing
Distributed: Nationwide in the USA and Puerto Rico
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Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Class II

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. 20230426 Ongoing
Distributed: Nationwide in the USA and Puerto Rico
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Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Class II

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. 20230426 Ongoing
Distributed: Nationwide in the USA and Puerto Rico
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DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Class II

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. 20230426 Ongoing
Distributed: Nationwide in the USA and Puerto Rico
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Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs Class II

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. 20230426 Ongoing
Distributed: Nationwide in the USA and Puerto Rico
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Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs Class II

Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. 20230426 Ongoing
Distributed: Nationwide in the USA and Puerto Rico
View Details
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