🍔 Food 💊 Drugs 🏥 Medical Devices
Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, 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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Valproic Acid Oral Solution, USP, 250mg/5mL, 473 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
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Tropicamide Ophthalmic Solution, USP 0.5%, 15 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
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Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- 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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Tobramycin Ophthalmic Solution, USP 0.3%, 5mL 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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Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, 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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Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL 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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Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured 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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Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, 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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Sodium DIURIL (chlorothiazide sodium), 0.5g/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
View Details
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