Akorn, Inc.
Akorn, Inc. appears in FDA public data with 192 recalls, 0 510(k) clearances, 6 FDA inspections, and 2 compliance actions on record. Its most recent recall (D-0840-2023, Class II) was initiated on April 26, 2023.
Summary
- Total Recalls
- 192
- 510(k) Clearances
- 0
- Inspections
- 6
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0840-2023 | Class II | Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating C | April 26, 2023 |
| D-0796-2023 | Class II | Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operatin | April 26, 2023 |
| D-0854-2023 | Class II | Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operat | April 26, 2023 |
| D-0833-2023 | Class II | Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., | April 26, 2023 |
| D-0862-2023 | Class II | Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed | April 26, 2023 |
| D-0826-2023 | Class II | Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn | April 26, 2023 |
| D-0820-2023 | Class II | Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Fo | April 26, 2023 |
| D-0803-2023 | Class II | Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Co | April 26, 2023 |
| D-0809-2023 | Class II | HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous U | April 26, 2023 |
| D-0858-2023 | Class II | Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., | April 26, 2023 |
| D-0824-2023 | Class II | Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed b | April 26, 2023 |
| D-0790-2023 | Class II | Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., | April 26, 2023 |
| D-0842-2023 | Class II | Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Onl | April 26, 2023 |
| D-0819-2023 | Class II | Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 m | April 26, 2023 |
| D-0783-2023 | Class II | Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Op | April 26, 2023 |
| D-0801-2023 | Class II | DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Dis | April 26, 2023 |
| D-0802-2023 | Class II | Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, | April 26, 2023 |
| D-0821-2023 | Class II | Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL C | April 26, 2023 |
| D-0792-2023 | Class II | Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operat | April 26, 2023 |
| D-0835-2023 | Class II | Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed | April 26, 2023 |