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- Recall Enforcement Event ID: 93357
Recall Enforment Report D-0300-2024
Recall Details
Multi event Drug Recall Enforcement Report Class I voluntary initiated by Kilitch Healthcare India Limited, originally initiated on 11-13-2023 for the product Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403 The product was recalled due to non-sterility. 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-0300-2024 | 11-13-2023 | 02-14-2024 | Class I | 401,568 bottles | Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403 | Non-Sterility | Ongoing |
| D-0310-2024 | 11-13-2023 | 02-14-2024 | Class I | 56,520 bottles | Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94 | Non-Sterility | Ongoing |
| D-0291-2024 | 11-13-2023 | 02-14-2024 | Class I | 210,192 bottles | Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017 | Non-Sterility | Ongoing |
| D-0290-2024 | 11-13-2023 | 02-14-2024 | Class I | 386,256 bottles | CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Non-Sterility | Ongoing |
| D-0295-2024 | 11-13-2023 | 02-14-2024 | Class I | 12,960 bottles | Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1 | Non-Sterility | Ongoing |
| D-0296-2024 | 11-13-2023 | 02-14-2024 | Class I | 253,080 bottles | CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15 | Non-Sterility | Ongoing |
| D-0294-2024 | 11-13-2023 | 02-14-2024 | Class I | 110,832 bottles | CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10 | Non-Sterility | Ongoing |
| D-0298-2024 | 11-13-2023 | 02-14-2024 | Class I | 150,720 bottles | CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Non-Sterility | Ongoing |
| D-0305-2024 | 11-13-2023 | 02-14-2024 | Class I | 45,408 bottles | CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15 | Non-Sterility | Ongoing |
| D-0299-2024 | 11-13-2023 | 02-14-2024 | Class I | 23,208 bottles | Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0089-1 | Non-Sterility | Ongoing |
| D-0311-2024 | 11-13-2023 | 02-14-2024 | Class I | 137,544 bottles | Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30 | Non-Sterility | Ongoing |
| D-0306-2024 | 11-13-2023 | 02-14-2024 | Class I | 7,200 bottles | Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5 | Non-Sterility | Ongoing |
| D-0302-2024 | 11-13-2023 | 02-14-2024 | Class I | 2,820 bottles | Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30 | Non-Sterility | Ongoing |
| D-0308-2024 | 11-13-2023 | 02-14-2024 | Class I | 9,216 bottles | Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3 | Non-Sterility | Ongoing |
| D-0309-2024 | 11-13-2023 | 02-14-2024 | Class I | 7,296 bottles | Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid | Non-Sterility | Ongoing |
| D-0301-2024 | 11-13-2023 | 02-14-2024 | Class I | 14,784 bottles | Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1 | Non-Sterility | Ongoing |
| D-0304-2024 | 11-13-2023 | 02-14-2024 | Class I | 6,024 bottles | LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5 | Non-Sterility | Ongoing |
| D-0292-2024 | 11-13-2023 | 02-14-2024 | Class I | 137,784 bottles | CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Non-Sterility | Ongoing |
| D-0297-2024 | 11-13-2023 | 02-14-2024 | Class I | 10,944 bottles | Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1 | Non-Sterility | Ongoing |
| D-0303-2024 | 11-13-2023 | 02-14-2024 | Class I | 33,984 bottles | EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01 | Non-Sterility | Ongoing |
| D-0307-2024 | 11-13-2023 | 02-14-2024 | Class I | 7,776 bottles | Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3 | Non-Sterility | Ongoing |
| D-0293-2024 | 11-13-2023 | 02-14-2024 | Class I | 1,492,344 bottles | Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94 | Non-Sterility | Ongoing |
Recall Enforcement Report D-0300-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0300-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 401,568 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0310-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0310-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 56,520 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0291-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0291-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 210,192 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0290-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0290-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 386,256 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0295-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0295-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 12,960 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0296-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0296-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 253,080 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0294-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0294-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 110,832 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0298-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0298-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 150,720 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0305-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0305-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 45,408 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0299-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0299-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0089-1
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 23,208 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0311-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0311-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 137,544 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0306-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0306-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7,200 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0302-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0302-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2,820 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0308-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0308-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 9,216 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0309-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0309-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7,296 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0301-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0301-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 14,784 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0304-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0304-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 6,024 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0292-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0292-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 137,784 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0297-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0297-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 10,944 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0303-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0303-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 33,984 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0307-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0307-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7,776 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
Recall Enforcement Report D-0293-2024
- Event ID
- 93357 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0293-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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 within the United States 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
- Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94
- Reason For Recall
- Non-Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,492,344 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
- 02-14-2024
- Recall Initiation Date
- 11-13-2023 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
- Press Release 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
- Kilitch Healthcare India Limited
- Code Info
- All lots 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. - Recalled NDC Packages
- Status
- Ongoing
