Akorn Recalls Expired Human and Animal Drugs Nationwide Due to Shutdown

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. Akorn has 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. Only products listed in the attachments are affected by the recall. Products not included in the press are continuing to be monitored under a Quality Program and will remain on the market. 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/retailers that have products which are being recalled should discard and contact their doctor.

Consumers with questions regarding this recall can contact Akorn at (800) 932-5676 during normal business hours (8am – 5pm 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.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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.

* Only products listed in the attachments are affected by the recall. Products not included in the press are continuing to be monitored under a Quality Program and will remain on the market.

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
Tropicamide Ophthalmic 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

Animal/Veterinary Product Description	Lot	Label
Artificial Tears	All NDCs and All Lots	https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec073766-70e5-42bd-965b-ce03eaa7d886 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5f44a1ee-4dd2-4a06-9721-578681148cbc https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=41199644-fa45-43e2-a056-24aed0fff745
Atropine Sulfate Ophthalmic Solution	All NDCs and All Lots	https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=590a4e7b-565f-415f-a8e4-499a382c9a3b
Butorphic Injection (butorphanol tartrate), 10 mg/mL	All NDCs and All Lots	https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa55a552-dadf-45d5-aba3-e63861621a5b https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6ef467e-d0cf-4b24-9f12-03ce5f4921be https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d8c22ab5-3053-4406-95b4-3dc3b17c2b9c
KETAMINE- ketamine hydrochloride injection, solution	All NDCs and All Lots	https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e457fc44-208d-4ca8-93aa-0f39dad0559f
Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment	All NDCs and All Lots	https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=492dcae6-d12b-4eaf-b346-e9960f01dd1c https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=853a0332-4da1-4a0d-a54a-f734c63e8b9d
Proparacaine HCl Ophthalmic Solution, 0.5%	All NDCs and All Lots	https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66e8723a-620c-42ed-a43e-cfa30014e1dc
Tobramycin Ophthalmic Solution 0.3%	All NDCs and All Lots	https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49dbd938-6c66-4835-af7f-923267f4568d
Vetaket 100 mg/mL Injection (ketamine HCl)	All NDCs and All Lots	https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e112c169-447a-4c25-961b-12de1722f431
VETORPHIC- butorphanol tartrate injection, solution	All NDCs and All Lots	https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4c8ef356-6a20-4e10-960b-a2f96026b42e

SOURCE Akorn, Inc.

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