FDA (Drugs) recall action 91788

Akorn, Inc. recalled 86 products on 2023-06-07

The FDA (Drugs) publishes a recall like this one as 86 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 86 pages.

Products: 86
Announced: 2023-06-07
Critical: 0
Units: —

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

76–86 of 86

HighFDA (Drugs)··2023-06-07
Rifampin Capsules Recall: Incomplete Stability Studies Due to Manufacturer Closure
Akorn Inc. is recalling all lots of Rifampin Capsules USP 300 mg distributed nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required testing.
Product
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
Category
Distribution
1 state
ModerateFDA (Drugs)··2023-06-07
Acyclovir Oral Suspension Recalled for Manufacturing Practice Deviations
Akorn's Acyclovir Oral Suspension is being recalled nationwide due to manufacturing practice deviations. The firm closed and could not complete required stability studies for the medication.
Product
Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Distribution
1 state
ModerateFDA (Drugs)··2023-06-07
Clobetasol Propionate Cream Recalled Due to CGMP Violations and Unverified Stability
Akorn, Inc. is recalling all lots of Clobetasol Propionate Cream 0.05% nationwide because the manufacturer went out of business before completing required stability studies to verify product safety and efficacy.
Product
Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Distribution
1 state
HighFDA (Drugs)··2023-06-07
Pilocarpine Hydrochloride Ophthalmic Solution Recalled for Manufacturing Compliance Deviations
The FDA has recalled all lots of Pilocarpine Hydrochloride Ophthalmic Solution 4% due to manufacturing process deviations. The distributor ceased operations and cannot complete required stability testing.
Product
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Distribution
1 state
ModerateFDA (Drugs)··2023-06-07
Clobetasol Propionate Shampoo Recall Due to Manufacturing Compliance Issues
Akorn, Inc. is recalling all lots of Clobetasol Propionate Shampoo, 0.05% distributed nationwide after the firm closed and could not continue required stability studies.
Product
Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Distribution
1 state
HighFDA (Drugs)··2023-06-07
Rifampin Capsules Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Rifampin Capsules USP 150 mg distributed nationwide due to manufacturing deviations. The company ceased business before completing required stability studies to verify the drug remains safe and effective throughout its shelf life.
Product
Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Distribution
1 state
HighFDA (Drugs)··2023-06-07
Timolol Maleate Ophthalmic Solution Recalled for Manufacturing and Stability Testing Defects
Akorn, Inc. has recalled all lots of Timolol Maleate Ophthalmic Solution 0.5% nationwide due to manufacturing quality deviations and inability to complete stability studies.
Product
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
Category
Distribution
1 state
HighFDA (Drugs)··2023-06-07
Levetiracetam Oral Solution Recalled Nationwide for Incomplete Stability Testing
Akorn, Inc. is recalling Levetiracetam Oral Solution nationwide after closing and failing to complete required FDA stability studies. The Class II recall affects all lots distributed in the United States and Puerto Rico.
Product
Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Category
Distribution
1 state
HighFDA (Drugs)··2023-06-07
Promethazine HCl Oral Solution Recalled Due to Manufacturing Deviations
Akorn, Inc. is recalling all lots of Promethazine HCl Oral Solution, USP, due to Current Good Manufacturing Practice deviations. The firm went out of business and cannot complete required stability studies.
Product
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
Category
Distribution
1 state
ModerateFDA (Drugs)··2023-06-07
Akorn Sodium Chloride Ophthalmic Ointment Recalled Due to Manufacturing Deviations
Akorn Inc. is recalling all lots of Sodium Chloride Ophthalmic Ointment 5% nationwide due to manufacturing practice deviations. The company ceased operations and could not continue stability studies required to verify the product's safety and effectiveness.
Product
Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Distribution
1 state
ModerateFDA (Drugs)··2023-06-07
Tobramycin Inhalation Solution Recalled Due to Incomplete Stability Studies
All lots of Tobramycin Inhalation Solution manufactured by Akorn, Inc. have been recalled nationwide due to CGMP deviations. The manufacturer was unable to complete required stability studies before ceasing operations.
Product
Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCs
Category
Distribution
1 state