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- Recall Enforcement Event ID: 90948
Recall Enforment Report D-0151-2023
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Akorn, Inc., originally initiated on 10-13-2022 for the product Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05 The product was recalled due to cgmp deviations:. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0151-2023 | 10-13-2022 | 01-25-2023 | Class II | 121,176 bottles | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05 | CGMP Deviations: | Ongoing |
D-0140-2023 | 10-13-2022 | 01-25-2023 | Class II | 196,254 bottles | GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12 | CGMP Deviations: | Ongoing |
D-0149-2023 | 10-13-2022 | 01-25-2023 | Class II | 173,928 bottles | Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12 | CGMP Deviations: | Ongoing |
D-0145-2023 | 10-13-2022 | 01-25-2023 | Class II | 2,082 tubes | Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35 | CGMP Deviations: | Ongoing |
D-0158-2023 | 10-13-2022 | 01-25-2023 | Class II | 91,692 bottles | Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05 | CGMP Deviations: | Ongoing |
D-0142-2023 | 10-13-2022 | 01-25-2023 | Class II | 3108 bottles | Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10 | CGMP Deviations: | Ongoing |
D-0148-2023 | 10-13-2022 | 01-25-2023 | Class II | 1,752 bottles | Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05 | CGMP Deviations: | Ongoing |
D-0133-2023 | 10-13-2022 | 01-25-2023 | Class II | 1,164,171 tubes | Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35 | CGMP Deviations: | Ongoing |
D-0136-2023 | 10-13-2022 | 01-25-2023 | Class II | 1,584 bottles | Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25 | CGMP Deviations: | Ongoing |
D-0144-2023 | 10-13-2022 | 01-25-2023 | Class II | 2,563 bottles | Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19 | CGMP Deviations: | Ongoing |
D-0141-2023 | 10-13-2022 | 01-25-2023 | Class II | 314,543 10ml,3ml, 5ml bottles | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. | CGMP Deviations: | Ongoing |
D-0139-2023 | 10-13-2022 | 01-25-2023 | Class II | 36,455 cartons | Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31 | CGMP Deviations: | Ongoing |
D-0154-2023 | 10-13-2022 | 01-25-2023 | Class II | 23,026 bottles | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15 | CGMP Deviations: | Ongoing |
D-0150-2023 | 10-13-2022 | 01-25-2023 | Class II | 163,996 bottles | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05 | CGMP Deviations: | Ongoing |
D-0153-2023 | 10-13-2022 | 01-25-2023 | Class II | 267,678 bottles | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12 | CGMP Deviations: | Ongoing |
D-0135-2023 | 10-13-2022 | 01-25-2023 | Class II | 6,273 bottles | Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10 | CGMP Deviations: | Ongoing |
D-0152-2023 | 10-13-2022 | 01-25-2023 | Class II | 51,601 bottles | PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12 | CGMP Deviations: | Ongoing |
D-0156-2023 | 10-13-2022 | 01-25-2023 | Class II | 1,310,324 bottles | Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. | CGMP Deviations: | Ongoing |
D-0137-2023 | 10-13-2022 | 01-25-2023 | Class II | 188,550 bottles | Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11 | CGMP Deviations: | Ongoing |
D-0143-2023 | 10-13-2022 | 01-25-2023 | Class II | 2,369,258 tubes | Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. | CGMP Deviations: | Ongoing |
D-0157-2023 | 10-13-2022 | 01-25-2023 | Class II | 2,095,068 bottles | Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10 | CGMP Deviations: | Ongoing |
D-0146-2023 | 10-13-2022 | 01-25-2023 | Class II | 65,006 bottles | Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05 | CGMP Deviations: | Ongoing |
D-0132-2023 | 10-13-2022 | 01-25-2023 | Class II | 36,025 tubes | AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35 | CGMP Deviations: | Ongoing |
D-0138-2023 | 10-13-2022 | 01-25-2023 | Class II | 1,109,600 tubes | ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35 | CGMP Deviations: | Ongoing |
D-0147-2023 | 10-13-2022 | 01-25-2023 | Class II | 31,073 bottles | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05 | CGMP Deviations: | Ongoing |
D-0134-2023 | 10-13-2022 | 01-25-2023 | Class II | 967,075 bottles | Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12 | CGMP Deviations: | Ongoing |
D-0155-2023 | 10-13-2022 | 01-25-2023 | Class II | 524,506 tubes | Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35 | CGMP Deviations: | Ongoing |
Recall Enforcement Report D-0151-2023
Recall Enforcement Report D-0140-2023
Recall Enforcement Report D-0149-2023
Recall Enforcement Report D-0145-2023
Recall Enforcement Report D-0158-2023
Recall Enforcement Report D-0142-2023
Recall Enforcement Report D-0148-2023
Recall Enforcement Report D-0133-2023
Recall Enforcement Report D-0136-2023
Recall Enforcement Report D-0144-2023
Recall Enforcement Report D-0141-2023
Recall Enforcement Report D-0139-2023
Recall Enforcement Report D-0154-2023
Recall Enforcement Report D-0150-2023
Recall Enforcement Report D-0153-2023
Recall Enforcement Report D-0135-2023
Recall Enforcement Report D-0152-2023
Recall Enforcement Report D-0156-2023
Field Name | Field Value |
---|---|
Event ID | 90948 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number | D-0156-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern | Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
Product Description | Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. |
Reason For Recall | CGMP Deviations: What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity | 1,310,324 bottles Product Quantity The amount of product subject to recall. |
Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date | 01-25-2023 |
Recall Initiation Date | 10-13-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type | Drugs |
Recalling Firm | Akorn, Inc. |
Code Info | Lot: (a) 0B50A, 0B69A, EXP 1/31/2023; 0C74A, EXP 2/28/2023; 0D04A, EXP 3/31/2023; 0E37A, EXP 4/30/2023; 0G07A, 0G82A, EXP 6/30/2023; 0H26A, 0H28A, 0H53A, 0H36A, EXP 7/31/2023; 0J64A, 0J58A, 0J66A, EXP 8/31/2023; 0K96A, 0K06A, 0K98A, 0K04A, 0K03A, 0K99A, EXP 9/30/2023; 0L72A, EXP 10/31/2023; 0M81A, 0M85A, 0M80A, 0M84A, 0M82A, 0M83A, EXP 11/30/2023; 1A01A, 1A02A, EXP 12/31/2023; 1B16A, 1B13A, 1B17A, EXP 1/31/2024; 1C51A, EXP 2/29/2024; (b) 0B59A , EXP 1/31/2023;0E49A, EXP 4/30/2023; 0G14A, EXP 6/30/2023; 0H38A, EXP 7/31/2023; 0J84A, EXP 8/31/2023; 0K05A, EXP 9/30/2023; 0L59A, EXP 10/31/2023; 0M86A, 0M87A, EXP 11/30/2023; 1A03A, EXP 12/31/2023; 1B37A, EXP 1/31/2024; 1C63A, EXP 2/29/2024; 1C54A, EXP 2/29/2024; 1D83A, EXP 3/31/2024; (c) 0C82A, EXP 2/28/2023; 0G84A, EXP 6/30/2023; 0H49A, EXP 7/31/2023; 0J77A, EXP 8/31/2023; 0J75A, EXP 8/31/2023; 0L57A, EXP 10/31/2023; 0L74A, EXP 10/31/2023; 0L46A, EXP 10/31/2023; 1G52A, EXP 6/30/2024; 1J52A, EXP 8/31/2024; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Status | Ongoing |
Recall Enforcement Report D-0137-2023
Recall Enforcement Report D-0143-2023
Field Name | Field Value |
---|---|
Event ID | 90948 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number | D-0143-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification | Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern | Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
Product Description | Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. |
Reason For Recall | CGMP Deviations: What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity | 2,369,258 tubes Product Quantity The amount of product subject to recall. |
Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date | 01-25-2023 |
Recall Initiation Date | 10-13-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Initial Firm Notification | Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type | Drugs |
Recalling Firm | Akorn, Inc. |
Code Info | Lot: (a) 0A02B, 0A02D, 0A02C, 0A02A, 0A02E, EXP 12/31/2022; 0B60C, 0B46B, 0B60D EXP 1/31/2023; 0B67B, 0B67D, 0B60B, 0B60A, 0B67A, 0B46D, 0B67C, 0B46A, EXP 1/31/2023; 0C78B, 0C78D, 0C78C, EXP 2/28/2023; 0D11A, 0D11C, 0D11B, 0D11D, EXP 3/31/2023 0E35C, 0E35B, 0E35A, EXP 4/30/2023; 0J63B, 0J63C, EXP 8/31/2023; 0K02A, 0K02C, 0K02D, 0K02B, EXP 9/30/2023; 0L47B, 0L47C, 0L47A, EXP 10/31/2023; 1B12B, 1B12A, 1B23A, 1B23F, 1B12C, 1B23B, 1B23D, 1B23E, 1B12D, EXP 1/31/2024; 1C66C, 1C66A, EXP 2/29/2024; 1D93B, 1D93D, 1D93C, 1D99B, 1D99C, 1D99A, 1D93A, 1D99D, EXP 3/31/2024 1H96C, 1H96D, 1H96E, EXP 7/31/2024; 1J37B, 1J47B, 1J47D, 1J37C, 1J37A, 1J47C, EXP 8/31/2024; 1L18D, 1L98C, 1L18C, 1L18A, 1L98B, 1L98D, 1L18B, 1L98E, EXP 10/31/2024; 2D21B, EXP 3/31/2025 (b) 0A06A, 0A37A , EXP 12/31/2022; 0B44A, EXP 1/31/2023; 0C88A, 0C84A, EXP 2/28/2023; 0D21A, 0D08A, EXP 3/31/2023; 0E46A, 0E46B, 0E31A, 0E48A, EXP 4/30/2023; 0F72A, 0F58A, EXP 5/31/2023; 0G05A, EXP 6/30/2023; 0H41A, EXP 7/31/2023; 0J67A, 0J67B, EXP 8/31/2023; 0K15B, 0K15A, EXP 9/30/2023; 0L56B, EXP 10/31/2023; 1B20A, EXP 1/31/2024; 1C47A, 1C52A, EXP 2/29/2024; 1D84B,1D84A, EXP 3/31/2024; 1G61A, 1G64A, 1G72A, EXP 6/30/2024; 1J51A, 1J28A, EXP 8/31/2024; 1K63A, 1K69A, 1K73A, 1K69B, 1K69C, EXP 9/30/2024; 1L15B, EXP 10/31/2024; 2C08A,EXP 2/28/2025; Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Status | Ongoing |