🍔 Food 💊 Drugs 🏥 Medical Devices
Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, 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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Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 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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Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 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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Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, 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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Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, 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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Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, 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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Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 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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Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, 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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Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 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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Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, 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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