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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. (Clicking on this link will take you to another website)
Akorn Recalled Items & Corresponding Hilco Vision 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
| Hilco Vision Item # | Hilco Vision Item Description | NDC | Recommended Alternate | Alternate Description |
| 1069857 | ERYTHRO 0.5% PF OPH OINT 50/BOX (AKORN) NDC 17478-0070-31 | 17478-070-31 | 1029352 | ERYTHROMYCIN 0.5% PRESERVATIVE FREE OPH OINT BX OF 50 |
| 1073828 | ERYTHROMYCIN 0.5% OINTMENT 3.5 GM | 17478-070-35 | 1029353 | ERYTHROMYCIN 0.5% PRESERVATIVE FREE OPH OINT 3.5GM |
| 1030512 | FUL GLO FLUORESCEIN STRIPS 0.6 MG 1/PKG 300/BOX | 17478-0403-03 | 1030513 | BIOGLO FLUORESCEIN STRIPS 1 MG 1/PKG 300/BOX |
| 1078037 | FUL-GLO FLUORESCEIN STRIPS 1MG 100/BOX | 17478-0404-01 | 1030511 | BIO GLO FLUORESCEIN STRIPS 1 MG 1/PKG 100/BOX |
| 1093780 | GATIFLOXACIN OPH SOL 0.5% 2.5ML (AKORN) | 50383-0189-02 | 1083943 | GATIFLOXACIN OPH 0.5% 2.5ML |
| 1029409 | GENTAK 0.3% OPH OINT 3.5 GM | 17478-284-35 | 1300561 | GENTAMICIN SULPHATE 0.3% 5ML SANDOZ |
| 1048969 | GENTAK 0.3% OPH SOLN 5 ML | 17478-283-10 | 1300561 | GENTAMICIN SULPHATE 0.3% 5ML SANDOZ |
| 1029400 | GONAK 2.5% OPH SOLN 15 ML | 17478-064-12 | ***1302822 | OPTASE DRY EYE INTENSE DROPS PF 10ML EA |
| 1099826 | KETOROLAC 0.5% 10ML OPHTH SOLUTION 17478-0209-11 | 17478-0209-11 | 1083381 | KETOROLAC SOLUTION 0.5% 10ML NDC 61314012610 |
| 1300596 | KETOROLAC 0.5% 5ML OPHTH SOLUTION 17478-0209-10 | 17478-0209-10 | 1073830 | KETOROLAC SO 0.5% 5ML NDC 61314-0126-05 |
| 1074698 | KETOTIFEN FURMARATE 0.025% 5ML | 17478-717-10 | 108404 | ZADITOR ANTIHISTAMINE DROPS 5ML |
| 1029411 | LIDOCAINE HCL 2% JELLY 10 PACK X 5 ML | 17478-711-31 | 1099953 | LIDOCAINE HCL JELLY 2% 20MG/ML 10ML 76329-3013-5 |
| 1100035 | LIDOCAINE HCL 2% JELLY 10X5ML NDC 17478-0711-31 | 17478-0711-31 | 1099953 | LIDOCAINE HCL JELLY 2% 20MG/ML 10ML 76329-3013-5 |
| 1029410 | LIDOCAINE HCL JELLY 2% 30 ML NDC 17478-0711-30 | 17478-711-30 | 1099953 | LIDOCAINE HCL JELLY 2% 20MG/ML 10ML 76329-3013-5 |
| 1097621 | LIDOCAINE+PRILOCAINE CREAM 2.5% 30GM NDC50383066730 | 50383-667-30 | N/A | N/A |
| 1029724 | METHYLENE BLUE 1% SDV 10 X 10 ML NDC 17478-0504-10 | 17478-0504-10 | N/A | N/A |
| 1099565 | OFLOXACIN 0.3% 10ML | 17478-0713-11 | 1099951 | B&L OFLOXACIN OPHTHALMIC SOLUTION 0.3% 10ML 24208-0434-10 |
| 1073827 | OFLOXACIN 0.3% 5 ML | 17478-0713-10 | 1041765 | B&L OFLOXACIN OPHTHALMIC SOLUTION .3% 5ML NDC 24208-434-05 |
| 1029520 | PAREMYD STERILE OPH SOLN 15ML | 17478-704-12 | N/A | N/A |
| 1029399 | PHENYLEPHRINE 10% OPH SOLUTION 5ML (AKORN) | 17478-0206-05 | 1029331 | PHENYLEPHRINE HCL 10% 5ML |
| 1069355 | PHENYLEPHRINE 2.5% OPH SOLUTION 15ML (AKORN) | 17478-0201-15 | 1301646 | PHENYLEPHRINE HCL 2.5% OPH SOLN 10ML 42702-0102-10 |
| 1069015 | PHENYLEPHRINE 2.5% OPH SOLUTION 2ML (AKORN) | 17478-0201-02 | 1301646 | PHENYLEPHRINE HCL 2.5% OPH SOLN 10ML 42702-0102-10 |
| 1076514 | SODIUM CHLORIDE OINTMENT PF 3.5GM 5.0% | 17478-622-35 | 1029563 | MURO 128 5% OPH OINT 3.5 GM |
| 1300217 | TIMOLOL MALEATE 0.5% OPH SOLN 10ML 17478-288-11 | 17478-0288-11 | 1029388 | TIMOLOL MALEATE 0.5% OPH SOLN 10 ML NDC 61314-0227-10 |
| 1300218 | TIMOLOL MALEATE 0.5% OPH SOLN 15ML 17478-288-12 | 17478-0288-12 | 1029389 | TIMOLOL MALEATE 0.5% OPH SOLN 15 ML NDC 61314-0227-15 |
| 1074396 | TIMOLOL MALEATE 0.5% OPH SOLN 5ML 17478-288-10 | 17478-288-10 | 1029387 | TIMOLOL MALEATE 0.5% OPH SOLN 5 ML |
| 1073829 | TOBRAMYCIN 0.3% 5 ML | 17478-290-10 | 1301970 | TOBRAMYCIN 0.3% 5ML SOLUTION 24208-290-05 |
| 1073650 | TRIMETHOPRIM/ POLYMYXIN B SULFATE 10ML | 17478-0703-11 | 1096705 | TRIMETHOPRIM/ POLYMYXIN B SULFATE 10ML |
| 1069745 | TROPICAMIDE 0.5% 15ML (AKORN) | 17478-101-12 | 1029320 | TROPICAMIDE 0.5% OPH SOLN 15 ML |
| 1069746 | TROPICAMIDE 1% 15ML (AKORN) | 17478-102-12 | 1029321 | TROPICAMIDE 1% OPH SOLN 15 ML |
*Please click on the FDA link above for the most up-to-date information regarding this recall.