🍔 Food 💊 Drugs 🏥 Medical Devices
Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 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
View Details
Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, 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
View Details
Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), 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
View Details
Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, 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
View Details
Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count 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
Rifampin Capsules USP, 150 mg, 30-count 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
Proparacaine HCl 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
View Details
Promethazine HCl Oral Solution, USP, 6.25 mg/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
View Details
Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, 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
Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 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
Page 260 of 1,805 | Showing 10 recalls
Data provided by openFDA