🍔 Food 💊 Drugs 🏥 Medical Devices
Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use 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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Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use 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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Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, 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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Acyclovir Oral Suspension, 200mg/5mL, 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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Acetic Acid Otic Solution, 15 mL per bottle, 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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Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, 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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Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, 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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Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25 Class III

Reason: Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

New England Life Care, Inc. dba Advanced Compounding Solutions 20230522 Terminated
Distributed: Nationwide in the USA.
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Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10 Class II

Reason: Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.

Fresenius Medical Care Holdings, Inc. 20230523 Terminated
Distributed: Product was distributed to 32 clinics in SC, NC and VA.
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HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2 Class II

Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

SSM Health Care St. Louis DBA SSM St. Clare Health Center 20230509 Ongoing
Distributed: Product was distributed in Missouri.
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