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.
FDA is recalling all lots of DetomiSed (detomidine hydrochloride), a prescription-only drug, nationwide. Akorn Inc., the manufacturer, went out of business and could no longer conduct stability studies.
Akorn, Inc. is recalling all lots of Proparacaine HCl Ophthalmic Solution 0.5% due to manufacturing deviations. The manufacturer could not complete required stability studies before going out of business.
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.
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.
Akorn Inc. is recalling all lots of Sufenta (Sufentanil Citrate Injection) distributed nationwide. The manufacturer ceased operations and could not complete required stability studies to verify drug safety and effectiveness over time.
Akorn recalls all lots of Tropicamide Ophthalmic Solution 0.5% (15 mL bottles) nationwide due to CGMP deviations. The firm was unable to complete required stability studies after ceasing operations.
Akorn is recalling all lots of Acetic Acid Otic Solution nationwide due to manufacturing practice deviations. The firm went out of business and could not complete stability studies required to verify the product remained safe and effective.
Akorn, Inc. is recalling all lots of DOCU LIQUID (docusate sodium) after the company ceased operations and could not complete mandatory stability testing required for FDA compliance.
Akorn Inc. is recalling all lots of Oxcarbazepine Oral Suspension 300 mg/5 mL due to manufacturing practice deviations. The firm went out of business and could not complete required stability studies.
Akorn, Inc. recalled all lots of Gonak Hypromellose Ophthalmic Solution distributed in the USA and Puerto Rico after the firm ceased operations and could not complete required stability studies.
Akorn, Inc. recalls all lots of Granisetron HCl Injection nationwide because the manufacturer ceased operations and cannot complete required stability studies, leaving the drug's shelf-life unverified.