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- Recall Enforcement Event ID: 93154
Recall Enforment Report D-0061-2024
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pine Pharmaceuticals, LLC, originally initiated on 10-02-2023 for the product Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0061-2024 | 10-02-2023 | 10-25-2023 | Class II | 130 | Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0058-2024 | 10-02-2023 | 10-25-2023 | Class II | 2176 syringes | Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0051-2024 | 10-02-2023 | 10-25-2023 | Class II | 26 vials | Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0065-2024 | 10-02-2023 | 10-25-2023 | Class II | 136 syringes | Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0053-2024 | 10-02-2023 | 10-25-2023 | Class II | 128 bags | Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0064-2024 | 10-02-2023 | 10-25-2023 | Class II | 860 syringes | Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0057-2024 | 10-02-2023 | 10-25-2023 | Class II | 4972 syringes | Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0062-2024 | 10-02-2023 | 10-25-2023 | Class II | 1598 droppers | Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0063-2024 | 10-02-2023 | 10-25-2023 | Class II | 662 dropper | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0056-2024 | 10-02-2023 | 10-25-2023 | Class II | 2484 syringes | Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0052-2024 | 10-02-2023 | 10-25-2023 | Class II | 201 kits | Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0054-2024 | 10-02-2023 | 10-25-2023 | Class II | 881 pre-filled syringes | Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0050-2024 | 10-02-2023 | 10-25-2023 | Class II | 2862 Syringes | Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0059-2024 | 10-02-2023 | 10-25-2023 | Class II | 9673 vials | Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0060-2024 | 10-02-2023 | 10-25-2023 | Class II | 1693 droppers | TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
| D-0055-2024 | 10-02-2023 | 10-25-2023 | Class II | 2181 droppers | Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Terminated |
Recall Enforcement Report D-0061-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0061-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 130 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 70101, Exp. Date 1/17/2024 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. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0058-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0058-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2176 syringes 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 67623, Exp. Date 10/15/2023; 67919, Exp. Date 10/29/2023; 68917, Exp. Date 12/16/2023; 69079, Exp. Date 12/23/2023; 69120, Exp. Date 12/24/2023 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
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0051-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0051-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 26 vials 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 69985, exp. date 11/15/2023 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
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0065-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0065-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 136 syringes 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 68680, Exp. Date 12/4/2023 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
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0053-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0053-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 128 bags 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 69802, Exp. Date 02/28/2024 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. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0064-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0064-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 860 syringes 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 67808, Exp. Date 10/23/2023 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
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0057-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0057-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4972 syringes 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 67918, Exp. Date 10/29/2023; 68033, Exp. Date 11/4/2023; 68515, Exp. Date 11/26/2023; 68528, Exp. Date 11/27/2023; 68618, Exp. Date 12/2/2023; 68651, Exp. Date 12/3/2023; 68767, Exp. Date 12/9/2023; 68829, Exp. Date 12/11/2023; 69820, Exp. Date 1/9/2024; 70733, Exp. Date 2/19/2024; 71068, Exp. Date 3/9/2024; 67345, Exp. Date 10/3/2023 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
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0062-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0062-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1598 droppers 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 67443, Exp. Date 10/8/2023; 68775, Exp. Date 12/9/2023 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
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0063-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0063-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 662 dropper 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 67659, Exp. Date 10/16/2023; 70316, Exp. Date 1/30/2024 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. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0056-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0056-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2484 syringes 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 67480, Exp. Date 10/9/2023; 68640,Exp. Date 12/3/2023; 68769, Exp. Date 12/9/2023; 68760, Exp. Date 12/10/2023; 68925, Exp. Date 12/16/2023;70119, Exp. Date 1/20/2024 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. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0052-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0052-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 201 kits 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 69986, Exp. Date 11/15/2023 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
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0054-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0054-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 881 pre-filled syringes 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 70363, Exp. Date 03/20/2024 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. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0050-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0050-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2862 Syringes 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 68622, 68620 Exp. Date 10/3/2023; 68632 Exp. Date 10/4/2023; 68699, 68704, 68706 Exp. Date 10/6/2023; 68726, 68740 Exp. Date 10/7/2023; 68784 Exp. Date 10/11/2023; 68843, 68861, Exp. Date 10/13/2023; 68789,68822 Exp. Date 10/12/2023; 68914 Exp. Date 10/17/2023; 68952, 68954, 68980 Exp. Date 10/18/2023; 69105 Exp. Date 10/25/2023; 69731 Exp. Date 11/7/2023; 69991 Exp. Date 11/15/2023;70142 Exp. Date 11/22/2023; 70233 Exp. Date 11/28/2023; 70297, 70264, 70291, 70300 Exp. Date 11/30/2023; 70355 Exp. Date 12/5/2023; 70516, 70513 Exp. Date 12/12/2023;;70659, 70664 Exp. Date 12/19/2023; 70700 Exp. Date 12/20/2023; 68912, Exp. Date 10/17/2023; 69071, Exp. Date 10/24/2023; 69725, Exp. Date 10/31/2023; 69749, Exp. Date 11/1/2023; 69961, Exp. Date 11/14/2023; 70112, Exp. Date 11/21/2023; 70228, Exp. Date 11/28/2023; 70353, Exp. Date 12/5/2023; 70403, Exp. Date 12/9/2023; 70513, Exp. Date 2/12/2023; 70569, 70570, 70579, 70571, 70572,70573, 70585, 70503 Exp. Date 12/14/2023; 70692, Exp. Date 12/20/2023; 68912, Exp. Date 10/17/2023; 69071, Exp. Date 10/24/2023; 69725, Exp. Date 10/31/2023; 69749, Exp. Date 1/7/2023; 69961, Exp. Date 11/14/2023; 70112, Exp. Date 11/21/2023; 70228, Exp. Date 11/28/2023; 70353, Exp. Date 12/5/2023; 70 692, Exp. Date 12/20/2023, 67538, Exp. Date 10/11/2023; 68535, Exp. Date 10/4/2023; 68611, 68613 Exp. Date 10/3/2023; 68612, 68633, 68637 Exp. Date 10/4/2023; 68638, 68673, 68674,68675, Exp. Date 10/5/2023; 68634, 68699, 68700, 68701, 68702, 68709 Exp. Date 10/6/2023; 68703, 68708, 68728, 68729, 68736, 68737, 68738, 68739, Exp. Date 10/7/2023; 68647, 68757, 68758, 68759, Exp. Date 10/10/2023; 68784, 68785, 68786, 68787, 68788, Exp. Date 10/11/2023; 68821, 68823, 68824, Exp. Date 10/12/2023; 68896, 68897, 68843, 68844, 68850, 68851, 68852, 10/13/2023; 68853 68877, 68878, 68879, 68880, 68886, 68890, 68891 Exp. Date 10/14/2023; 68913, 68915, 68923, Exp. Date 10/17/2023; 68922, 68953,68976, 68980, Exp. Date 10/18/2023; 68977, 68978,68979, 68981, Exp. Date 10/19/2023; 68959,68982, 69016, 69017, 69019, 69012 Exp. Date 10/20/2023; 69018, 69047, 69048, 69049, 69050, 69051, 69052, 69056, 68983, 69042, Exp. Date 10/21/2023; 69072, 69073, 69074, 69075, Exp. Date 10/24/2023; 69102, 69103, 69104, 69105, 69109, Exp. Date 10/25/2023; 69129, 69127, 69077 Exp. Date 10/26/2023; 69142, 69128, Exp. Date 10/27/2023; 69130, 69101, 69131, 69132, 69143, 69144, 69166, 69167, 69168, 69169, 69170, 69171, Exp. Date 10/28/2023; 69726, 69727, Exp. Date 10/31/2023;69746, 69748, 69750, Exp. Date 11/2/2023; 69754, 69755, 69768, 69770, Exp. Date 11/3/2023; 69779, 69751, 69745, 69780, 69781, 69782, 69783, 69784, 69793, Exp. Date 11/4/2023; 69794, 6974, ; 69841, Exp. Date 11/8/2023; 69865, 69866, 69863, 69867, 69796, 69872 Exp. Date 11/9/2023; 69890, 69892,69893, 69894, 69895, 69896, 69897, Exp. Date 11/10/2023; 69928, 69929, 69930,69931,69932, 69933, 69928, 69950, Exp. Date 11/11/2023; 69964, 69868, Exp. Date 11/14/2023; 69965, 69987, 69988, 69990, Exp. Date 11/15/2023; 70031, 70032, 70033, 69963, 70034, Exp. Date 11/16/2023; 70066,70067, Exp. Date 11/17/2023; 69998,70011,69962, 70094, 70095, 69864, 70093 Exp. Date 11/18/2023; 70035, 70113, 70114, 70115, Exp. Date 11/21/2023; 70116, 70138, 70139, 70140, 70147, Exp. Date 11/22/2023; 70163, 70164, 70165, 70166, 70167, 70168, Exp. Date 11/23/2023; 70191, 70193,70194, 70195, 70196, 70197, 70198, 70204, Exp. Date 11/24/2023; 70208, 70211, 70212, 70213, 70214, 70220, 70218, Exp. Date 11/25/2023; 70229, 70231, 70232, 70234, Exp. Date 11/28/2023; 70254, 70255, 70256, 70257, 70261, 70262, 70263, 70277, 70258, 70275 Exp. Date 11/29/2023; 70265, 70314, 70315, 70259,70299 Exp. Date 12/1/2023; 70325, 70326, 70333,70338, 70341 Exp. Date 12/2/2023; 70358, Exp. Date 12/5/2023; 70397, 70398, 70399, 70399, 70409, 70410, 70406, 70404 Exp. Date 12/6/2023; 70324, 70339, 70445, 70450, Exp. Date 12/7/2023; 70462, 70463, 70465, 70466, 70467, Exp. Date 12/8/2023; 70494, 70495, 70497, 70493, 70497, 70501, 70422 Exp. Date 12/9/2023; 70523, 70419, 70514, Exp. Date 12/12/2023;70544, 70549, 70552, 70553, Exp. Date 12/13/2023; 70605,70606, 70340, 70608,70609, 70613, 70619 Exp. Date 12/15/2023; 70635, 70636, Exp. Date 12/16/2023; 70660, 70661, 70662, 70663, 12/19/2023; 70672, 70693, 70694,70695,70696, 70702, Exp. Date 12/20/2023; 70726, 70727, 70728, 70729, 70730, 70744, 70731, Exp. Date 12/21/2023; 70759, 70760, 70762, 70763, Exp. Date 12/22/2023; 70786,70791, 70788, 70789 Exp. Date 12/23/2023; 70835, 70787, 70790, Exp. Date 12/26/2023; 70852, 70853, 70860, 70833 Exp. Date 12/27/2023; 70868, 70869, 70870, 70871, 70874, Exp. Date 12/28/2023; 70832, 70851, Exp. Date 1/4/2024. 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. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0059-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0059-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 9673 vials 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 67849, Exp. Date 10/25/2023; 67887, Exp. Date 10/28/2023; 68260, Exp. Date 11/14/2023; 68534, Exp. Date 11/27/2023; 68816, Exp. Date 12/12/2023; 69046, Exp. Date 12/20/2023; 69971, Exp. Date 1/13/2024 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. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0060-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0060-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1693 droppers 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 68184, Exp. Date 10/9/2023; 68623, Exp. Date 11/2/2023 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
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0055-2024
- Event ID
- 93154 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0055-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class 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 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
- Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Reason For Recall
- Lack of Assurance of Sterility What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2181 droppers 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
- 10-25-2023
- Recall Initiation Date
- 10-02-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-15-2024 What is the Date Terminated?
The date that FDA terminated 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
- Pine Pharmaceuticals, LLC
- Code Info
- Lot #: 67008, Exp. Date 10/04/2023; 67685, Exp. Date 10/21/2023; 67853, Exp. Date 10/25/2023; 69967, Exp. Date 01/13/2024 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. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
