Multi-event August 2015 FDA Recall Drug by Pharmakon Pharmaceuticals

This Multi-event Class II drug recall was voluntarily initiated by Pharmakon Pharmaceuticals on August 19, 2015 for the product Drug. The FDA reported the reason for recall as stability data does not support expiry.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0588-2016 TERMINATED D-0606-2016 TERMINATED D-0594-2016 TERMINATED D-0597-2016 TERMINATED D-0602-2016 TERMINATED D-0593-2016 TERMINATED D-0605-2016 TERMINATED D-0601-2016 TERMINATED D-0608-2016 TERMINATED D-0603-2016 TERMINATED D-0598-2016 TERMINATED D-0607-2016 TERMINATED D-0590-2016 TERMINATED D-0600-2016 TERMINATED D-0595-2016 TERMINATED D-0591-2016 TERMINATED D-0609-2016 TERMINATED D-0592-2016 TERMINATED D-0596-2016 TERMINATED D-0589-2016 TERMINATED D-0604-2016 TERMINATED D-0599-2016 TERMINATED

Recall Number: D-0588-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
4123

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0606-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0594-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
4100

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0597-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
475

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0602-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
250

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0593-2016

Reason for Recall
Subpotent drug.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
210

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0605-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
378

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0601-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
525

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0608-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0603-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
5000

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0598-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
8000

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0607-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0590-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0600-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
600

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0595-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
665

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0591-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
5875

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0609-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0592-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
2750

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0596-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
7100

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0589-2016

Reason for Recall
Subpotent drug.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
1150

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0604-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
400

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015

Recall Number: D-0599-2016

Reason for Recall
Stability data does not support expiry.
Initiated
08-19-2015
Reported
02-03-2016
Quantity
1530

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72177
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmakon Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2017
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# All lots with expiration dates up to 11/17/2015