Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown (2024)

GURNEE, Ill., April 26, 2023 /PRNewswire/ --Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various within-expiry human and animal products as a result of the closures and discontinuation of the Quality activities of these marketed products. (Refer to Attachment I and II). The discontinuation of the Quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately.

Risk Statement:The discontinuation of the Quality program would result in the company's inability to assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess which render the products adulterated. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products. Akornhas not received any reports of adverse events related to this recall.

The affected products are listed in Attachment I (human drugs) and II (animal drugs) of this release. The products were distributed nationwide to Wholesalers, Retailers, Manufacturers, Medical Facilities, and Repackagers and via the Internet to Consumers.

Akorn is notifying its distributors and direct consignees by direct mailing and is requesting they further notify their customers/consumers/retailers. Akorn is requesting destruction of any recalled products.Consumers/distributors/retailersthat haveproductswhich are being recalled shoulddiscard and contact their doctor.

Consumers with questions regarding this recall can contactAkornat (800) 932-5676 during normal business hours (8am5pm CDT) Monday – Friday. A qualified medical professional will return your call within one business day. Consumers should contact their physician, their healthcare provider or veterinarian if they, or animals in their care, have experienced any problems that may be related to taking or using these drug products.

For human drug products, adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

For animal drug products, adverse reactions or quality problems experienced with the use of animal drug products may be reported to FDA's Center for Veterinary Medicine Adverse Event Reporting program by completing an online Form FDA 1932a available at www.fda.gov/reportanimalae.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Description

Lot

Label

Acetaminophen & Codeine Phosphate Oral Solution 120mg & 12mg/5mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=83a536d8-385d-46ed-9cd2-47b7efe96ccf

Acetic Acid Otic Solution

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c53fc11e-b177-446e-839d-391e1b2eacff

Acyclovir Oral Suspension, 200mg/5mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=62bdcf22-51f3-4c81-9bd4-a2dc48bec580

Albuterol Sulfate Syrup, 2mg (base)

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3544356-e36a-4ce6-8235-cb0531c658ad

Amantadine HCl Syrup, USP 50 mg per 5mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7ef565b0-00ac-428e-b00c-e0c905659ecd

Apraclonidine Ophthalmic Solution 0.5%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dc7d3a9f-c0b9-411c-9c62-0a14f1718b00

Artificial Tears

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7479297-1ebc-4752-93b5-e4ad7f8c47f5

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=63284a57-c93d-47a0-8a0f-c583868f19bc

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=736f9577-d8ff-45c7-8205-dfdb7193492f

Atropine Sulfate Ophthalmic Solution

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f7b40bf1-3063-4849-a5a0-0ac5d0d1e72a

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6818d479-860a-422e-be16-6589392b063f

Azelastine Hydrochloride Nasal Spray, 0.1%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dc7d3a9f-c0b9-411c-9c62-0a14f1718b00

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fc69f672-17ec-4d86-b5af-086fd260b512

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, 3.5g

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b750666-18f2-40f5-9fb3-87457001b485

Calcipotriene Scalp Solution, 0.005%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c9942a-e861-493f-95c2-53446bc5f06d

Calcitriol Injection 1 mcg and 2 mcg

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4d6046c2-4a28-47b1-9bb4-51fadeded2d2

Cetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose Vial

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=41f00c84-d1f1-47a5-a42c-a577cc29a548

Ciclopirox Topical Solution 8%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4439cb3d-6825-4558-a981-122ec15f7b05

Cimetidine HCl Oral Solution

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f2ec923a-2b88-43c0-ac2a-7ae20c053039

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b27f10b3-3913-401c-90a4-f92dc5de763e

Clobetasol Propionate Cream 0.05%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb29b17b-96af-4a78-bc91-83cf8c5c2b1d

Clobetasol Propionate Ointment, 0.05%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb29b17b-96af-4a78-bc91-83cf8c5c2b1d

Clobetasol Propionate Shampoo, 0.05%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d16ac961-bb76-4aab-9ad7-737f1958c057

Cromolyn Sodium Ophthalmic Solution 4%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e604ed4d-d8a7-4f65-a386-b4bd6137d987

Detomidine Hydrochloride 20mL and 5mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80bd1b24-bf51-47c4-b859-64cfdba79fbc

Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL)

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e1592ba-03cd-4831-bd7c-4c0eeaa06fd1

Diuril® (chlorothiazide sodium) Injection

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5046a4d7-7742-4f19-930a-2582cb41474e

DOCU LIQUID- docusate sodium liquid

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7fdc4368-4888-4792-86d3-c8a828e4fff2

Ephedrine Injection 50 mg/mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=490334c5-dbac-4a18-9e13-fc9ef5484e41

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=378bd48c-78c4-4d48-8835-c53bb5d9ccc2

Ferrous Sulfate Elixir and Iron Supplement

All NDCs and All Lots

https://www.akorn.com/prod-details-list.php?group=Ferrous+Sulfate+Iron+Supplement+Drops&

Fluticasone Propionate Nasal Spray

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7ea1841-2fb1-48c8-86f9-639893fd1a84

Gonak Hypromellose Ophth Sol

All NDCs and All Lots

https://fda.report/NDC/17478-064

Granisetron HCl Injection 1 mg/mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=02f350c9-b7d2-4906-af28-70ed4461ff23

Guaifenesin and Codeine Phosphate Liquid

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b920eba2-27f2-402c-a7c9-d0988977965c

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5cb704a7-301c-494e-948f-872ee0d5a289

HydrALAZINE HCl Injection

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e31239e0-8c5a-4d10-9404-af32278484a3

Hydrocortisone and Acetic Acid Otic Solution

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ffd1edc1-2f40-4b0a-a53a-9fb53b8d3184

Hydromorphone High Potency Injection USP – Ampule and Vial

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4d33b072-0755-4b8c-9558-2551306756a3

IC-Green Sterile Indocyanine Green Injection USP

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fe138b13-43e1-4ab2-8882-07ed91bb70ea

Ketorolac Tromethamine Ophthalmic Solution, 0.5%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3196b192-439c-4a71-a002-358efdd5b6e6

Lactulose Syrup (Oral) and (Oral/Rectal)

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff6b4568-1383-46b6-a1c6-385fc31fb210

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=19455240-16b6-4e25-a5c9-a6c965e5ec19

Levetiracetam Injection USP, 500 mg/5 mL (100 mg/mL) single-dose vial

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cb8aed34-2f3b-48b1-86ea-84b0d9e2b618

Levocarnitine Oral Solution, USP

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3563c2f5-9814-4d55-8d90-bd7d6dcff36b

Levofloxacin Injection, 25 mg/mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4438fed2-7ef5-488f-baa8-39bc65768d1d

Levofloxacin Oral Solution

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6c7322b-6a89-4d23-90d1-bf9327bd6d91

Levofloxacin Opth Solution

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6987500a-2feb-48a9-9d29-89693333a801

Lidocaine 2.5% & Prilocaine 2.5% Cream

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9378d186-5b25-49bc-8563-a659fa1194c2

Lidocaine Ointment

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f9303361-534d-4daa-bb4f-29992a0232dc

Lidocaine HCl Jelly USP, 2%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=317a8784-5fdd-429f-9b74-14d89f372a32

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff6b27bc-2ed7-4292-b8c8-da910bf68167

Lorazepam Injection 2 mg/mL vial

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5b17cde-a94c-4105-871c-54e7d2bd47e8

Lorazepam Oral Concentrate, 2mg

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=73bfaeab-94db-48c2-a194-8b173025de78

Megestrol Acetate Oral Suspension 40 mg/mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f7676cd-469b-450b-b064-339b84d4047f

Midazolam Injection USP 1 mg/mL & 5 mg/mL - vial

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=737361a0-8db1-4d3c-ba5e-44df3f49fa22

Moxifloxacin HCl Solution 0.5%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe08

Naloxone Injection 0.4 mg/mL; 1 mL and 10mL Vial

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=747e602c-93f9-4723-a899-4c1c55c35ef8

Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3cac80c3-0798-4f8a-9756-d5b05d3d2dca

Olopatadine HCl Nasal Spray, 665 mcg/spray

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f42d26f8-c583-411b-b17f-b3ca9eaba7a2

Olopatadine Solution 0.1% and 0.2%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e513d024-f121-495e-9957-f2e1da272a48

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd115efc-8d68-3e01-e053-2a95a90af93c

Oxcarbazepine Oral Suspension USP, 300 mg/5 mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=461c2a54-1d5a-494b-9137-0dcb9ca83c79

Pilocarpine 1, 2, & 4%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa03947c-6844-45df-aa22-b584c5681269

Prednisolone Sodium Phosphate Oral Solution

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6b201232-4a52-487c-b963-a98539469e5d

Promethazine HCl & Codeine Phosphate Oral Solution

All NDCs and All Lots

https://fda.report/NDC/50383-804

Promethazine HCl Oral Solution

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bd8d1f9a-242c-440b-a5eb-a50f64a1c1d9

Proparacaine HCl Ophthalmic Solution, 0.5%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=37cde651-2549-43f3-97b9-cdc442a0aa7a

Rifampin Capsules USP, 150 mg & 300 mg

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=26a2dbca-5090-4f6c-99ed-e11a70bb5af0

Ropivacaine Hydrochloride Injection USP, 0.2% and 5mg/mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=187fccbf-329a-4af1-a16e-f13c0e2bd73d

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3f538ea5-1e08-4fb5-9756-696ac3d817a3

Fentanyl Citrate Injection

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5d40297-b769-48cc-9f84-f98b7a333507

Sodium Chloride Ophthalmic Ointment

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e00f4d11-0999-452a-87bb-4d477db294a6

Sodium Chloride Solution Drops

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab12c419-4b1a-4119-9e23-76ce7a89d1a7

Sodium DIURIL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d9fa4e6-6516-45cd-a316-292c6a529ecc

Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=95e639db-1ca3-4328-b347-7ea348f6cc72

Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06e3d76b-8f16-4d53-bb9f-201cb6a72fb8

Timolol Maleate Ophthalmic Solution 0.5%, 2.5, 5, 10, & 15mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9726422-f794-4d39-a437-17dcb8c0f3b5

Tobramycin Inhalation Solution USP, 300 mg/5 mL

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=be8368d7-bfd0-47e8-8d69-ac5f4a4851ed

Tobramycin Ophthalmic Solution 0.3%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c91db5e0-f6b8-40d7-b307-b24073b9705e

Trihexyphenidyl HCl Oral Sol

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=294cd88d-d9e8-4938-b4be-c3adc4a35de0

TropicamideOphthalmic Solution 0.5% and 1%

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=329a3382-3718-4311-890f-97c6b7e0077c

Valproic Acid Oral Solution

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=84bbc23d-9bd3-4d48-9b64-d6eef64214b4

Vitamin D Suppl. Drops 50mL

All NDCs and All Lots

https://www.akorn.com/prod-details-list.php?group=Vitamin+D+Supplement+Drops&

XOPENEX- levalbuterol hydrochloride solution, concentrate

All NDCs and All Lots

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0c47c47d-45f7-4eb4-b1f8-7d6c633a1f69

SOURCE Akorn, Inc.

Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown (2024)

References

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