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

This Multi-event Class II drug recall was voluntarily initiated by Pharmedium Services, Llc on July 17, 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-0068-2017 TERMINATED D-0073-2017 TERMINATED D-0092-2017 TERMINATED D-0033-2017 TERMINATED D-0029-2017 TERMINATED D-0085-2017 TERMINATED D-0040-2017 TERMINATED D-0035-2017 TERMINATED D-0060-2017 TERMINATED D-0079-2017 TERMINATED D-0059-2017 TERMINATED D-0065-2017 TERMINATED D-0087-2017 TERMINATED D-0057-2017 TERMINATED D-0030-2017 TERMINATED D-0052-2017 TERMINATED D-0039-2017 TERMINATED D-0062-2017 TERMINATED D-0077-2017 TERMINATED D-0032-2017 TERMINATED D-0051-2017 TERMINATED D-0091-2017 TERMINATED D-0048-2017 TERMINATED D-0025-2017 TERMINATED D-0089-2017 TERMINATED D-0027-2017 TERMINATED D-0075-2017 TERMINATED D-0083-2017 TERMINATED D-0067-2017 TERMINATED D-0055-2017 TERMINATED D-0078-2017 TERMINATED D-0081-2017 TERMINATED D-0044-2017 TERMINATED D-0076-2017 TERMINATED D-0058-2017 TERMINATED D-0056-2017 TERMINATED D-0074-2017 TERMINATED D-0034-2017 TERMINATED D-0046-2017 TERMINATED D-0037-2017 TERMINATED D-0072-2017 TERMINATED D-0061-2017 TERMINATED D-0069-2017 TERMINATED D-0049-2017 TERMINATED D-0082-2017 TERMINATED D-0050-2017 TERMINATED D-0054-2017 TERMINATED D-0053-2017 TERMINATED D-0036-2017 TERMINATED D-0066-2017 TERMINATED D-0038-2017 TERMINATED D-0042-2017 TERMINATED D-0063-2017 TERMINATED D-0026-2017 TERMINATED D-0047-2017 TERMINATED D-0064-2017 TERMINATED D-0093-2017 TERMINATED D-0080-2017 TERMINATED D-0031-2017 TERMINATED D-0090-2017 TERMINATED D-0086-2017 TERMINATED D-0041-2017 TERMINATED D-0084-2017 TERMINATED D-0028-2017 TERMINATED D-0071-2017 TERMINATED D-0088-2017 TERMINATED D-0043-2017 TERMINATED D-0045-2017 TERMINATED D-0070-2017 TERMINATED

Recall Number: D-0068-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
1161 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441, NDC 61553-441-80

Batch or Lot Expiration Information

Lot# Lot Numbers: 15121068M, 15128035M, 15134056M, 15148067M, 15152003M, 151890376M, Exp between 07/15/15-10/12/15

Recall Number: D-0073-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
1700 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15124046M, 15125056M, 15127070M, 15127073M, 15138054M, 15147055M, 15149049M, 151880314M, 151890307M, Exp between 07/15/15-10/12/15

Recall Number: D-0092-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
499 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.

Batch or Lot Expiration Information

Lot# Lot Number: 15112122M, Exp between 07/15/15-10/12/15

Recall Number: D-0033-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
50 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40

Batch or Lot Expiration Information

Lot# Lot Number: 15141053M, Exp between 07/15/15-10/12/15

Recall Number: D-0029-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
995 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3301.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15112081M, 15113016M, Exp between 07/15/15-10/12/15

Recall Number: D-0085-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
380 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3376.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15113035M, 15112047M, Exp between 07/15/15-10/12/15

Recall Number: D-0040-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
1561 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15103037M, 15117042M, 15126027M, 15127049M, 15131003M, 15119043M, 15138050M, 15141033M, 15142056M, 15146040M, 15149039M, 151890299M, 151900220M, 151930019M, Exp between 07/15/15-10/12/15

Recall Number: D-0035-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
8955 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15118074M, 15120007M, 15124007M, 15127060M, 15132006M, 15132039M, 15138059M, 15139012M, 15139051M, 15140003M, 15141067M, 15146006M, 15148075M, 151730112M, 151730155M, 151740205M, 151880329M, 151930020M, 151930026M, Exp between 07/15/15-10/12/15

Recall Number: D-0060-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
2961 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15118064M, 15119066M, 15119075M, 15124006M, 15133061M, 15133066M, 15134057M, 15140063M, 15149053M, 151720021M, 151880315M, Exp between 07/15/15-10/12/15

Recall Number: D-0079-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
21506 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3259.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15125021M, 15126043M, 15126064M, 15126065M, 15126066M, 15127091M, 15132014M, 15133011C, 15134006C, 15134007C, 15134062M, 15135063M, 15139087M, 15141002C, 15141040M, 15141041M, 15146081M, 15147036M, 15147037M, 15147122M, 15148003C, 15148012M, 15148119M, 15149003M, 15152004C, 15153006C, 15154002C, 15155007C, 15160009C, 151650003C 151660005C, 151660006C, 151670005C, 151720005C, 151720041C, 151730003M, 151730006C, 151730007C, 151730128M, 151740131M, 151740136M, 151750007C, 151790041C, 151930021M, Exp between 07/15/15-10/12/15

Recall Number: D-0059-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
3285 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3140.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15118068M, 15124072M. 15125066M, 15128033M, 15131001M, 15131017M, 15139035M, 15139080M, 15146036M, 15147054M, 15152078M, 151730126M, 151740218M, 151900292M, Exp between 07/15/15-10/12/15

Recall Number: D-0065-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
6324 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3112.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15118067M, 15120045M, 15127005M, 15131002M, 15135005M, 15135046M, 15140001M, 15140045M, 15146007M, 15147070M, 15152052M, 151880331M, 151900241M, Exp between 07/15/15-10/12/15

Recall Number: D-0087-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
2985 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3346.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15112107M, 15112110M, 15112113M, 15113025, 15113077M, 15113092M, Exp between 07/15/15-10/12/15

Recall Number: D-0057-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
54 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe, Rx only, PharMEDium, For IV Use, Product code 2R3500.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15117045M, 15120050M, 15131014M, Exp between 07/15/15-10/12/15

Recall Number: D-0030-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
1478 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3308.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15112085M, 15112087M, 15112090M, 15113020M, 15113100M, Exp between 07/15/15-10/12/15

Recall Number: D-0052-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
450 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165

Batch or Lot Expiration Information

Lot# Lot Numbers: 15133058M, 15140061M, 15147056M, 151880295M, Exp between 07/15/15-10/12/15

Recall Number: D-0039-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
1522 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15100054M, 15117048M, 15127063M, 15128034M, 15128044M, 15132059M, 15134032M, 15147063M, 15148055M, 151890302M, 151900130M, 151900222M, Exp between 07/15/15-10/12/15

Recall Number: D-0062-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
499 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3106.

Batch or Lot Expiration Information

Lot# Lot Number: 15113014M, Exp between 07/15/15-10/12/15

Recall Number: D-0077-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
935 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15117038M, 151200111M, 15126052M, 15127038M, 15131015M, 15134028M, 15134031M, 15135049M, 151380104M, 15139033M, 15139063M, 151410121M, 15146038M, 15147041M, 15149045M, 15152036M, 151730212M, 151890291M, 151930131M, Exp between 07/15/15-10/12/15

Recall Number: D-0032-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
210 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.

Batch or Lot Expiration Information

Lot# Lot Numbers: 151000045M, 15127040M, 15133026M, 15141029M, 151930078M, 15132103M, Exp between 07/15/15-10/12/15

Recall Number: D-0051-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
4860 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15121069M, 15124075M, 15126078M, 15138012M, 15138013M, 15148077M, 15149122M, 15150103M, 151740201M, 151880159M, 151890210M, Exp between 07/15/15-10/12/15

Recall Number: D-0091-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
4400 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15118063M, 15119033M, 15124035M, 15132062M, 15135014C, 15138006M, 15146004M, 15147009C, 15152042M, 15155003C, 15160004C, 151680013C, 151730130M, 151900142M, 151950033M, Exp between 07/15/15-10/12/15

Recall Number: D-0048-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
240 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 USP Heparin Units per mL, Rx only, PharMEDium, Product code 2K1925.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15147130S, 15180094S, Exp between 07/15/15-10/12/15

Recall Number: D-0025-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
4407 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15146085M, 15147088M, 15149011M, 15149109M, 15150093M, 151730001M, 151740139M, 151900018M, 151910014M, Exp between 07/15/15-10/12/15

Recall Number: D-0089-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
6970 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.

Batch or Lot Expiration Information

Lot# Lot Numbers: 151120168M, 151120169M, 15112027M, 15112096M, 15113021M, 15113080M, 15113081M, 15113082M, 15113083M, 15113084M, 15113085M, 15113086M, 15113087M, 15113088M, Exp between 07/15/15-10/12/15

Recall Number: D-0027-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
660 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15194041E, 15195008E, 15195020E, Exp between 07/15/15-10/12/15

Recall Number: D-0075-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
26079 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356.

Batch or Lot Expiration Information

Lot# Lot Numbers: 151170045M, 151170084M, 151170093M, 15117084M, 151180080M, 15118092M, 15118094M, 15119054M, 15120072M, 15121093M, 151240093M, 151240094M, 151240099M, 15124074M, 151250094M, 15126044M, 15126079M, 15126080M, 15127097M, 15127098M, 15128112M, 151310092M, 151310103M, 151310105M, 15131028M, 151320099M, 15133012M, 15133081M, 15134068M,15134069M, 151380068M, 151380106M, 151380112M, 151390138M, 15139090M, 15140088M, 15140089M, 15141045M, 15141074M, 15141075M, 151450030M, 151450032M, 151460097M, 15146083M, 15146087M, 15149001M, 15149005M, 15149118M, 15149119M, 15150104M, 15152056M, 151720012M, 151730078M, 151730138M, 151740019M, 151740141M, 151740143M, 151890127M, 151890128M, 151890305M, 151900021M, 151900022M, 151900140M, 151930073M, 151930171M, 151930173M, Exp between 07/15/15-10/12/15

Recall Number: D-0083-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
250 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550.

Batch or Lot Expiration Information

Lot# Lot Numbers: 151880279M, 151890275M, 151930119M, Exp between 07/15/15-10/12/15

Recall Number: D-0067-2017

Reason for Recall
Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
512 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3384.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15112074M, 15113030M, Exp between 07/15/15-10/12/15

Recall Number: D-0055-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
9101 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3330.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15118003M, 15119077M, 15121002M, 15125019M, 15126067M, 15132022M, 15132038M, 15134043M, 15139009M, 15140006M, 15141004M, 15141065M, 15148045M, 15148070M, 151730156M, 151890125M, 151890208M, 151900010M, 151900125M, 151930044M, 151940270M, Exp between 07/15/15-10/12/15

Recall Number: D-0078-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
592 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3181.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15113049M, 15113050M, Exp between 07/15/15-10/12/15

Recall Number: D-0081-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
25 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455.

Batch or Lot Expiration Information

Lot# Lot number: 15125033M, Exp between 07/15/15-10/12/15

Recall Number: D-0044-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
16366 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15100141M, 15118066M, 15118083M, 15121090M, 15124001M, 15126042M, 15127036M, 15128030M, 15132065M, 15133010M, 15134007M, 15135010M, 15138062M, 15139002M, 15139003M, 15139052M, 15139053M, 15140083M, 15142002M, 15142090M, 15146084M, 15148044M, 15150014M, 15153002M, 151720016M, 151740133M, 151880151M, 151890120M, 151890239M, 151900019M, 151910015M, 151930042M, Exp between 07/15/15-10/12/15

Recall Number: D-0076-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
3270 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3017.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15121035M, 15125026M, 15126061M, 15132040M, 15133041M, 15139084M, 15147038M, 15148024M, 15152044M, 151740022M, 151900205M, Exp between 07/15/15-10/12/15

Recall Number: D-0058-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
969 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15112079M, 15112124M, Exp between 07/15/15-10/12/15

Recall Number: D-0056-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
12,173 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15117083M, 15117090M, 15118047M, 15121052M, 15124079M, 15126020M, 15127007M, 15127096M, 15133014M, 15133068M, 15134067M, 15139089M, 15140069M, 15141027M, 15141043M, 15142095M, 15146008M, 15149111M, 15149116M, 151730004M, 151730116M, 151880152M, 151890126M, 151930170M, 151940024M, 151940182M, Exp between 07/15/15-10/12/15

Recall Number: D-0074-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
4058 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product Code 2R3351.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15124077M, 15126077M, 15128005M, 15131033M, 15133007C, 15133080M, 15135013C, 15138066M, 15139013C, 15141044M, 15154009C, 15160005C, 151740043C, 151800047C, 151900147M, Exp between 07/15/15-10/12/15

Recall Number: D-0034-2017

Reason for Recall
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
4347 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15100052M, 15103048M, 15104052M, 15118032M, 15127009M, 15127068M, 15134039M, 15135009M, 15135054M, 15140070M, 15147039M, 15148065M, 151900145M, 151930043M, Exp between 07/15/15-10/12/15

Recall Number: D-0046-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
1494 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3340.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15112008M, 15112040M, 15113024M, Exp between 07/15/15-10/12/15

Recall Number: D-0037-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
53357 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3303.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15119083M, 15119086M, 15133078M, 15134127M, 15135064M, 151380066M, 15138007M, 151380108M, 151380109M, 15138060M, 15138063M, 15138064M, 15138065M, 15140043M, 15140082M, 15140084M, 15142093M, 151450033M, 151460093M, 151460094M, 15147097M, 15149047M, 15149108M, 15149112M, 15149113M, 15152051M, 15152053M, 15160010C, 15161003C, 15161004C, 15161007C, 15161008C, 15163003C, 151650036C, 151660042C, 151660043C, 151670006C, 151670007C, 151670008C, 151680044C, 151720006C, 151720013M, 151720106M, 151730140M, 151730141M, 151730143M, 151740003C, 151740004C, 151740137M, 151750008C, 151760042C, 151790004C, 151790040C, 151880332M, 151890122M, 151890123M, 151900009M, 151900137M, 151900178M, 151900243M, 151930033M, 15100140M, 151020015M, 151020016M, 15103004M, 151030057M, 151030092M, 151170046M, 151170087M, 151170088M, 151170089M, 15120066M, 15120068M, 15124083M, 151260091M, 15127016M, 15127089M, 15127092M, 15127093M, 15128108M, 15128109M, 151310088M, 151310089M, 151310101M, 151310102M, 151310104M, 15132007C, 151320098M, 15133003C, 15133013C, 15135011C, 15138006C, 15139012C, 15141001C, 15142004C, 15142005C, 15147001C, 15147002C, 15147003C, 15147004C, 15147013C, 15147014C, 15149005C, 15152009C, 15154007C, 15155001C, 15155009C, 15156004C, 15157003C, 15159004C, Exp between 07/15/15-10/12/15

Recall Number: D-0072-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
7556 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15118069M, 15126004M, 151320095M, 15132023M, 15133005C, 15133011M, 15133032M, 15140003C, 15141005C, 15153010C, 151390098M, 15139065M, 15140074M, 151450122M, 15146010M, 15147052M, 15148046M, 15148058M, 15152062M,15160001C, 151680006C, 151720023M, 151720080M, 151730133M, 151740008C, 151740211M, 151800043C, 151880168M, Exp between 07/15/15-10/12/15

Recall Number: D-0061-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
500 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3104.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15117146M, 15121045M, 15125052M, 15131008M, 15133051M, 15140028M, 15149043M, 151890293M, Exp between 07/15/15-10/12/15

Recall Number: D-0069-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
3159 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3450.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15117053M, 15117054M, 15124056M, 15128001M, 15128002M, 15131021M, 15133067M, 15141028M, 15147089M, 15147090M, 151740185M, 151740188M, Exp between 07/15/15-10/12/15

Recall Number: D-0049-2017

Reason for Recall
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
350 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15138094S, 15148074S, 15152062S, 15159110S, 15180117S, 15183118S, Exp between 07/15/15-10/12/15

Recall Number: D-0082-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
21053 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3326.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15112030M, 15112033M, 15112034M, 15112099M, 15112101M, 15112103M, 15112105M, 15112108M, 15113001M, 15113002M, 15113003M, 15113007M, 15113032M, 15113033M, 15113075M, 15113076M, 15159002S, 15159003S, 15159004S, 15159006S, 15159007S, 15159009S, 15159011S, 15174213S, 15175035S, 15175036S, 15175037S, 15176015S, 15176016S, 15176017S, 15176018S, 15176020S, 15176021S, 15176022S, 15176024S, 15177011S, 15177012S, 15177013S, 15177016S, 15177017S, 15177018S, 15177019S, 15180245S, Exp between 07/15/15-10/12/15

Recall Number: D-0050-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
1916 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162.

Batch or Lot Expiration Information

Lot# Lot Numbers: 151200003M, 151260128M, 151300005M, 151310094M, 151320134M, 151320143M, 151340107M, 151370002M, 151390005M, 151390142M, 151400005M, 151400095M, 151400136M, 151470008M, 151510002M, 151520080M, 151880214M, 151890257M, Exp between 07/15/15-10/12/15

Recall Number: D-0054-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
1500 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3320.

Batch or Lot Expiration Information

Lot# Lot Numbers: 151120100M, 15112020M, 15112094M, 15113012M, Exp between 07/15/15-10/12/15

Recall Number: D-0053-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
25 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3234.

Batch or Lot Expiration Information

Lot# Lot Number: 15112064M, Exp between 07/15/15-10/12/15

Recall Number: D-0036-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
110 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15140057M, 15147053M, 15127066M, Exp between 07/15/15-10/12/15

Recall Number: D-0066-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
830 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79

Batch or Lot Expiration Information

Lot# Lot Numbers: 15119047M, 15124043M, 151340072M, 15134037M, 15148042M, Exp between 07/15/15-10/12/15

Recall Number: D-0038-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
997 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15112083M, 15112129M, Exp between 07/15/15-10/12/15

Recall Number: D-0042-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
1735 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15119048M, 15126024M, 15127055M, 15133037M, 15135039M, 15138039M, 15140022M, 15141026M, 15148023M, 15152075M, 151730221M, 151890289M, 151900214M, Exp between 07/15/15-10/12/15

Recall Number: D-0063-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
5900 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345.

Batch or Lot Expiration Information

Lot# Lot numbers: 15118046M, 15128003M, 15128111M, 15133006M, 15139004M, 15140015C, 15146086M, 15150029M, 15153004M, 151660012C, 151720052C, 151730131C, 151740007C, 151750019C, 151760011C, 151800048C,151880154M, Exp between 07/15/15-10/12/15

Recall Number: D-0026-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
5568 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15146082M, 15147001M, 15147099M, 15149110M, 15150028M, 15152055M, 151730002M, 151730129M, 151880317M, 151880330M, 151890300M, 151930022M, 151940213M, 151940288M, Exp between 07/15/15-10/12/15

Recall Number: D-0047-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
399 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2K1210.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15135098S, 15146063S, 15154082S, Exp between 07/15/15-10/12/15

Recall Number: D-0064-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
300 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3391.

Batch or Lot Expiration Information

Lot# Lot Number: 15113065M, Exp between 07/15/15-10/12/15

Recall Number: D-0093-2017

Reason for Recall
Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
500 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.

Batch or Lot Expiration Information

Lot# Lot Number: 15149004M, Exp 08/27/15

Recall Number: D-0080-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
545 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15118049M, 15126025M, 15131016M, 15133030M, 15139058M, 15140053M, 15142047M, 15146041M, 15147034M, 15149046M, 151720071M, 151880293M, 151930114M, Exp between 07/15/15-10/12/15

Recall Number: D-0031-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
1545 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3347.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15118028M, 15118062M, 15125027M, 15126055M, 15131013M, 15133028M, 15139046M, 15146033M, 15146062M, 151880294M, 151890279M, 151930127M, 151940261M, Exp between 07/15/15-10/12/15

Recall Number: D-0090-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
2495 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15112035M, 15112036M, 15113006M, 15113026M, 15113078M, Exp between 07/15/15-10/12/15

Recall Number: D-0086-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
498 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3109.

Batch or Lot Expiration Information

Lot# Lot Number: 15112121M, Exp between 07/15/15-10/12/15

Recall Number: D-0041-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
616 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15103031M, 15127041M, 15139034M, 15140039M, 15141048M, 15147057M, 15147086M, 15148053M, 151880285M, Exp between 07/15/15-10/12/15

Recall Number: D-0084-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
700 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3551.

Batch or Lot Expiration Information

Lot# Lot Numbers: 151890186M, 151900229M, 151900255M, 151930138M, 151940246M, Exp between 07/15/15-10/12/15

Recall Number: D-0028-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
10 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475.

Batch or Lot Expiration Information

Lot# Lot Number: 15195070E, Exp between 07/15/15-10/12/15

Recall Number: D-0071-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
200 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6134.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15149041M, 151720043M, 15100060M, 15127064M, Exp between 07/15/15-10/12/15

Recall Number: D-0088-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
1623 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300.

Batch or Lot Expiration Information

Lot# Lot Numbers: 151680012C, 151720013C, 151730179M, 151740029M, 151790014C, 151880319M, 151890297M, 151890318M, 151900127M, 151930081M, Exp between 07/15/15-10/12/15

Recall Number: D-0043-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
10 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a 3 mL BD Syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6107.

Batch or Lot Expiration Information

Lot# Lot Number: 151900252M, Exp between 07/15/15-10/12/15

Recall Number: D-0045-2017

Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
17462 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3329.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15117086M, 15117087M, 15117088M, 15118090M, 15120069M, 15120070M, 15124086M, 15126074M, 15126075M, 15127031M, 15127095M, 15133009M, 15133079M, 15134011M, 15134022M, 15134065M, 15140004M, 15140046M, 15140086M, 15141022M, 15141023M, 15141042M, 15142094M, 15147098M, 15149114M, 15149115M, 151520082M, 151520100M, 151520101M, 151520102M, 15152054M, 151740174M, 151880153M, 151890124M, 151900020M, 151910018M, Exp between 07/15/15-10/12/15

Recall Number: D-0070-2017

Reason for Recall
Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.
Initiated
07-17-2015
Reported
10-19-2016
Quantity
7006 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73925
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.
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.
06-23-2017
Product Description About Product Description
Full technical description of the product.
methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120.

Batch or Lot Expiration Information

Lot# Lot Numbers: 15118004M, 15119082M, 15134004C, 15134006M, 15139004C, 15139011M, 15140071M, 15141001M, 15141129M, 15147012C, 15147030M, 15148004C, 15150021M, 15155002C, 15160002C, 15160006C, 151730013C, 151760016C, 151810002C, 151890129M, Exp between 07/15/15-10/12/15