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- Recall Enforcement Event ID: 72177
Recall Enforment Report D-0588-2016
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pharmakon Pharmaceuticals, originally initiated on 08-19-2015 for the product Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. The product was recalled due to stability data does not support expiry.. 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-0588-2016 | 08-19-2015 | 02-03-2016 | Class II | 4123 | Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0606-2016 | 08-19-2015 | 02-03-2016 | Class II | N/A | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0594-2016 | 08-19-2015 | 02-03-2016 | Class II | 4100 | Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0597-2016 | 08-19-2015 | 02-03-2016 | Class II | 475 | Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0602-2016 | 08-19-2015 | 02-03-2016 | Class II | 250 | Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0593-2016 | 08-19-2015 | 02-03-2016 | Class II | 210 | Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Subpotent drug. | Terminated |
| D-0605-2016 | 08-19-2015 | 02-03-2016 | Class II | 378 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0601-2016 | 08-19-2015 | 02-03-2016 | Class II | 525 | Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0608-2016 | 08-19-2015 | 02-03-2016 | Class II | N/A | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0603-2016 | 08-19-2015 | 02-03-2016 | Class II | 5000 | Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0598-2016 | 08-19-2015 | 02-03-2016 | Class II | 8000 | Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0607-2016 | 08-19-2015 | 02-03-2016 | Class II | N/A | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0590-2016 | 08-19-2015 | 02-03-2016 | Class II | N/A | Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0600-2016 | 08-19-2015 | 02-03-2016 | Class II | 600 | Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0595-2016 | 08-19-2015 | 02-03-2016 | Class II | 665 | Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0591-2016 | 08-19-2015 | 02-03-2016 | Class II | 5875 | Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0609-2016 | 08-19-2015 | 02-03-2016 | Class II | N/A | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0592-2016 | 08-19-2015 | 02-03-2016 | Class II | 2750 | Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0596-2016 | 08-19-2015 | 02-03-2016 | Class II | 7100 | Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0589-2016 | 08-19-2015 | 02-03-2016 | Class II | 1150 | Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Subpotent drug. | Terminated |
| D-0604-2016 | 08-19-2015 | 02-03-2016 | Class II | 400 | Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
| D-0599-2016 | 08-19-2015 | 02-03-2016 | Class II | 1530 | Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Terminated |
Recall Enforcement Report D-0588-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0588-2016 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 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
- Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4123 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0606-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0606-2016 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 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
- Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0594-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0594-2016 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 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
- Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4100 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0597-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0597-2016 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 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
- Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 475 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0602-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0602-2016 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 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
- Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 250 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0593-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0593-2016 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 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
- Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Subpotent drug. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 210 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0605-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0605-2016 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 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
- Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 378 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0601-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0601-2016 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 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
- Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 525 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0608-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0608-2016 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 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
- Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0603-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0603-2016 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 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
- Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5000 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0598-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0598-2016 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 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
- Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 8000 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0607-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0607-2016 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 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
- Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0590-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0590-2016 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 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
- Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0600-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0600-2016 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 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
- Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 600 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0595-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0595-2016 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 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
- Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 665 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0591-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0591-2016 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 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
- Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5875 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0609-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0609-2016 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 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
- Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- N/A 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0592-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0592-2016 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 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
- Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2750 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0596-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0596-2016 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 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
- Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7100 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0589-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0589-2016 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 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
- Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Subpotent drug. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1150 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0604-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0604-2016 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 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 HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 400 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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-0599-2016
- Event ID
- 72177 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0599-2016 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 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
- Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Reason For Recall
- Stability data does not support expiry. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1530 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
- 02-03-2016
- Recall Initiation Date
- 08-19-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 05-09-2017 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Telephone 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
- Pharmakon Pharmaceuticals
- Code Info
- All lots with expiration dates up to 11/17/2015 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.
