Recalls

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

***URGENT DRUG RECALL NOTICE***

FDA PUBLISH DATE: April 26, 2023

SUPPLIER: Akorn Operating Company LLC

PRODUCT TYPE: Drugs (See table below for listing of affected NDCs).

 

Description:

The Akorn Trustee is voluntarily recalling all lots of the affected items due to discontinuation of the Quality activities of these marketed products as a result of Akorn filing Chapter 7 bankruptcy on February 23, 2023. This recall is to the Consumer level. Akorn has not received any reports of adverse events related to this recall.

 

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. Akorn has not received any reports of adverse events related to this recall.

 

Retailer/Customer Information:

Hilco Vison Customer, please examine your inventory for the affected products completely and stop dispensing immediately.  If you have the affected products, Akorn is requesting destruction of any recalled products.  Product should be destroyed in accordance with Federal, State, and Local laws and regulations.

 

Information contained in this document was provided by the FDA.

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Akorn Recalled Items & Corresponding eyecareandcure.com Reference Numbers

 

 

Only products listed below 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.

 

ECC Item#	ECC Item Description	NDC	Recommended Alternate	Alternate Description
1060072	Apraclonidine Ophthalmic Solution 5ml	17478-716-10	103457	Sandoz Apraclonidine HCl 0.5%, 5 ml
102718	Artificial Tears 1.4%, 15ml Ophthalmic solution	17478-060-12	1302822	OPTASE DRY EYE INTENSE DROPS PF 10ML EA
102720	Artificial Tears Ointment, 3.5 gr ***DISC by MFR - DO NOT B/O***	17478-062-35	102228	Refresh P.M.®, 3.5 gr ointment
101510	Atropine Sulfate 1% 15ml	17478-215-15	101512	Atropine Sulfate 1.0%, 3.5 g
101513	Atropine Sulfate 1% 2ml	17478-215-02	101512	Atropine Sulfate 1.0%, 3.5 g
101511	Atropine Sulfate 1% 5ml	17478-215-05	101512	Atropine Sulfate 1.0%, 3.5 g
1060073	Bromfenac 0.9%, 1.7 ml	50383-249-71	N/A	N/A
102713	Cromolyn Sodium 4% 10ml Solution	17478-291-11	1060185	Sandoz Cromolyn Sodium 4%, 10 ml
101525	Cyclopentolate, 2.0%, 15 ml	17478-0097-12	101519	Cyclogyl®, 2.0%, 15 ml
101527	Cyclopentolate, 2.0%, 2 ml	17478-0097-02	101519	Cyclogyl®, 2.0%, 15 ml
101526	Cyclopentolate, 2.0%, 5 ml	17478-0097-10	101519	Cyclogyl®, 2.0%, 15 ml
003-0000477-50	ERYTHRO 0.5% PF OPH OINT 50/BOX (AKORN) NDC 17478-0070-31	17478-070-31	1060485	Erythromycin, 1 gr, 50/box
104025	Erythromycin Ointment, 3.5gr, Akorn Brand	17478-070-35	104031	B&L Erythromycin, 3.5 gr
1060027	Ful-Glo Fluorescein Strips 0.6 mg, 300/box	17478-0403-03	101641	Bio-Glo™ Fluorescein Strips, 300/box
1060028	Ful-Glo Fluorescein Strips 1.0 mg, 100/box	17478-0404-01	101640	Bio-Glo™ Fluorescein Strips, 100/box
101670	Gonak 15ml	17478-064-12	***1302822	OPTASE DRY EYE INTENSE DROPS PF 10ML EA
101632	ICG Dye, 6/pack, Akorn Brand	17478-0701-02	101630	Indocyanine-Green, 6/pk
030-1663053-00	Ketorolac Tromethamine 0.5%, 10 ml ***DISC by MFR - DO NOT B/O - See SUB 1060066***	17478-209-10	1060066	Sandoz Ketorolac Tromethamine 0.5%, 10 ml
104534	Ketorolac Tromethamine 0.5%, 3ml ***DISC by MFR - DO NOT B/O - See SUB 1060065 (4 Feb 2019)***	17478-209-19	1060065	Sandoz Ketorolac Tromethamine 0.5%, 5 ml
1060022	Ketorolac Tromethamine 0.5%, 5ml	N/A	1060065	Sandoz Ketorolac Tromethamine 0.5%, 5 ml
102710	Ketotifen Fumarate 0.025%, 5 ml	17478-717-10	N/A	N/A
1060266	Levofloxacin HCL 0.5%, 5ml Solution	17478-106-10	104039	Sandoz Ciprofloxacin HCl 0.3%, 5 ml
107118	Lidocaine and Prilocaine Cream 2.5% , 30g	50383-667-30	N/A	N/A
003-3498359-00	LIDOCAINE HCL 2% JELLY 10 PACK X 5 ML	17478-711-31	105862	Lidocaine HCl Jelly 2.0% 20 mg/ml, 200 mg, PF, 10 ml topical
003-0071131-10	LIDOCAINE HCL 2% JELLY 10 PACK X 5 ML	17478-0711-31	105862	Lidocaine HCl Jelly 2.0% 20 mg/ml, 200 mg, PF, 10 ml topical
003-1747830-00	Lidocaine HCl 2% Jelly, 30 ml	17478-711-30	105862	Lidocaine HCl Jelly 2.0% 20 mg/ml, 200 mg, PF, 10 ml topical
104046	Ofloxacin HCl 0.3%, 10 ml	17478-0713-11	1099951	B&L Ofloxacin HCl 0.3%, 10 ml
101560	Paremyd 15ml Solution	17478-704-12	N/A	N/A
1060229	Physostigmine Salicylate 1mg/ml, 10/pkg	17478-0510-02	N/A	N/A
1060178	Pilocarpine 1.0%, 15 ml	17478-223-12	103562	Sandoz Pilocarpine HCl, 1.0% 15 ml
1060179	Pilocarpine 2.0%, 15 ml	17478-224-12	103563	Sandoz Pilocarpine HCl, 2.0% 15 ml
1060180	Pilocarpine 4.0%, 15 ml	17478-226-12	103564	Sandoz Pilocarpine HCl, 4.0% 15 ml
101569	Proparacaine .5% 15ml	17478-263-12	101570	B&L Proparacaine HCl 0.5%, 15 ml
102234	Sodium Chloride 5.0%, 3.5 gr ointment	17478-622-35	006-0062847-00	MURO 128 5% OPH OINT 3.5 GM
1060452	Timolol Maleate Ophth Sol, 0.5%, 15mL, 1 Bottle / EA	17478-0288-12	103575	Sandoz Timolol Maleate 0.5%, 15 ml
104067	Tobramycin 0.3% 5ml Solution	17478-290-10	104069	B&L Tobramycin Sulfate 0.3%, 5 ml
1060075	Tobramycin 40 mg/ml, 30 ml, each	17478-114-30	1060318	Tobramycin Sulfate 40mg/ml, 2ml 25/pk
101586	Tropicamide .5% 15ml Solution	17478-101-12	101580	B&L Tropicamide 0.5%, 15 ml
101579	Tropicamide 1% 15ml Solution	17478-102-12	101581	B&L Tropicamide 1.0%, 15 ml
103455	Zioptan 0.0015%, 0.3 ml, 30/box	17478-0609-30	N/A	N/A

 

*Please click on the FDA link above for the most up-to-date information regarding this recall.