Multi-event January 2015 FDA Recall Drug by Pharmedium Services, Llc

This Multi-event Class I drug recall was voluntarily initiated by Pharmedium Services, Llc on January 28, 2015 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1825-2015 TERMINATED D-1826-2015 TERMINATED D-1828-2015 TERMINATED D-1824-2015 TERMINATED D-1821-2015 TERMINATED D-1823-2015 TERMINATED D-1827-2015 TERMINATED D-1822-2015 TERMINATED

Recall Number: D-1825-2015

Reason for Recall
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Initiated
01-28-2015
Reported
09-30-2015
Quantity
663 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71844
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmedium Services, LLC
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2017
Product Description About Product Description
Full technical description of the product.
Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50

Batch or Lot Expiration Information

Lot# : 14303122M, Exp 01/28/15; 14309029M, Exp 02/02/15; 14315067M, Exp 02/09/15; 14317040M, Exp 02/11/15; 14318026M, Exp 02/12/15; 14323089M, Exp 02/17/15; 14325128M, 14325124M, Exp 02/19/15

Recall Number: D-1826-2015

Reason for Recall
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Initiated
01-28-2015
Reported
09-30-2015
Quantity
84 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71844
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmedium Services, LLC
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2017
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-156-50

Batch or Lot Expiration Information

Lot# : 14310063S, Exp 02/04/15; 14316086S, Exp 02/10/15; 14322138S, Exp 02/16/15

Recall Number: D-1828-2015

Reason for Recall
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Initiated
01-28-2015
Reported
09-30-2015
Quantity
120 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71844
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmedium Services, LLC
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2017
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-149-50

Batch or Lot Expiration Information

Lot# : 14308086S, Exp 02/02/15; 14309051S, Exp 02/03/15

Recall Number: D-1824-2015

Reason for Recall
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Initiated
01-28-2015
Reported
09-30-2015
Quantity
100 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71844
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmedium Services, LLC
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2017
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-181-50

Batch or Lot Expiration Information

Lot# : 14308162M, Exp 02/02/15; 143130049M, Exp 02/08/15; 143220039M, Exp 02/16/15; 143490058M, Exp 03/16/15; 143560029M, Exp 03/23/15

Recall Number: D-1821-2015

Reason for Recall
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Initiated
01-28-2015
Reported
09-30-2015
Quantity
240 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71844
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmedium Services, LLC
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2017
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-171-50

Batch or Lot Expiration Information

Lot# : 14310039S, Exp 11/06/14; 14318006S, Exp 11/17/14; 14321060S, Exp11/07/14

Recall Number: D-1823-2015

Reason for Recall
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Initiated
01-28-2015
Reported
09-30-2015
Quantity
20 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71844
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmedium Services, LLC
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2017
Product Description About Product Description
Full technical description of the product.
Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50

Batch or Lot Expiration Information

Lot# : 143140080M, Exp 02/09/15; 143210133M, Exp 02/16/15; 143490031M, Exp 03/16/15

Recall Number: D-1827-2015

Reason for Recall
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Initiated
01-28-2015
Reported
09-30-2015
Quantity
48 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71844
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmedium Services, LLC
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2017
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-236-50

Batch or Lot Expiration Information

Lot# : 14317035S, Exp 02/11/15

Recall Number: D-1822-2015

Reason for Recall
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Initiated
01-28-2015
Reported
09-30-2015
Quantity
24 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71844
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pharmedium Services, LLC
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2017
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-169-50

Batch or Lot Expiration Information

Lot# : 14309095S, Exp 02/03/15; 14311008S, Exp 02/05/15