FDA (Drugs) recall action 91788
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.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
The agency’s own wording, quoted from the enforcement report.
Akorn recalled all lots of Calcitriol Injection 2 mcg/mL nationwide due to CGMP deviations and inability to complete stability studies after the firm went out of business.
Akorn, Inc. is recalling all lots of Ketorolac Tromethamine Ophthalmic Solution 0.5% because the manufacturer went out of business and cannot complete required stability testing.
Akorn, Inc. is recalling all lots of Clobetasol Propionate Ointment 0.05% due to manufacturing practice violations and inability to complete required stability studies. Product was distributed nationwide in the USA and Puerto Rico.
Akorn, Inc. is recalling all lots of Midazolam Injection nationwide due to manufacturing practice deviations. The company ceased operations and could not complete stability studies to verify the drug's safety and efficacy.
Akorn Operating Company is recalling all lots of Sodium Chloride Ophthalmic Solution (5%, 50mg/mL) nationwide because the firm went out of business and could not complete required stability studies to verify product safety and effectiveness.
The FDA is recalling all lots of Olopatadine HCl Nasal Spray (665 mcg, manufactured by Akorn) nationwide and in Puerto Rico due to manufacturing quality deviations and incomplete stability studies.
Akorn, Inc. is recalling all lots of Albuterol Sulfate Syrup nationwide due to CGMP deviations. The firm went out of business and could not complete required stability studies to verify ongoing product safety and effectiveness.
Akorn, Inc. is recalling all lots of Olopatadine HCl Ophthalmic Solution, USP 0.1% eye drops due to Current Good Manufacturing Practice deviations. The manufacturer discontinued required stability studies after ceasing operations.
Akorn, Inc. has recalled all lots of Levofloxacin Injection nationwide due to manufacturing process violations and inability to complete required stability studies.
Akorn, Inc. recalls all lots of Lidocaine Ointment USP 5% (1 1/4 oz tubes) distributed nationwide due to CGMP deviations. The manufacturer could not complete required stability studies after closing operations.
Akorn, Inc. is recalling all lots of Fentanyl Citrate Injection nationwide due to manufacturing compliance deviations. The company was unable to complete required stability studies after ceasing operations.
Akorn, Inc. is recalling all lots of Lorazepam Oral Concentrate (2 mg/mL) due to Current Good Manufacturing Practice deviations. The manufacturer went out of business and could not complete required stability studies.
Akorn, Inc. is recalling all lots of Atropine Sulfate Ophthalmic Solution USP 1% because the firm went out of business and could not complete required stability studies. The product was distributed nationwide in the USA and Puerto Rico.
Akorn, Inc. is recalling all lots of Guaiatussin AC Sugar-Free nationwide due to manufacturing deviations. The firm went out of business and could not continue stability studies.
Akorn, Inc. is recalling all lots of Levofloxacin Ophthalmic Solution 0.5% due to manufacturing practice deviations. The firm went out of business and could not continue required stability studies.
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.
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.
Ciclopirox 8% topical solution (nail lacquer) is recalled nationwide. The manufacturer went out of business and could not complete required stability testing to ensure product safety.
Akorn is recalling all lots of Artificial Tears Ointment nationwide due to manufacturing compliance deviations. The company went out of business and was unable to complete required stability studies.
Akorn, Inc. is recalling all lots of Lidocaine 2.5% & Prilocaine 2.5% Cream due to CGMP deviations. The manufacturer went out of business and could not complete required stability studies to verify product integrity.
Akorn, Inc. is recalling all lots of Olopatadine HCl ophthalmic solution 0.2% because the company went out of business and can no longer conduct required stability testing.
Akorn, Inc. is recalling all lots of Ephedrine Sulfate Injection due to manufacturing compliance deviations; the firm was unable to complete required stability studies.
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.
Akorn, Inc. recalls all lots of Ropivacaine Hydrochloride Injection nationwide because the manufacturer went out of business and cannot complete required stability studies.
Akorn, Inc. recalls all lots of AK-POLY-BAC ophthalmic ointment nationwide because the company ceased operations and could not complete required stability testing.