Multi-event February 2017 FDA Recall Drug by Pharmedium Services, Llc
This Multi-event Class II drug recall was voluntarily initiated by Pharmedium Services, Llc on February 17, 2017 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
D-0915-2017 D-0906-2017 D-0914-2017 D-0909-2017 D-0911-2017 D-0913-2017 D-0907-2017 D-0910-2017 D-0912-2017 D-0916-2017 D-0908-2017
Recall Number: D-0915-2017
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
02-17-2017
06-21-2017
60 bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Batch or Lot Expiration Information
Lot# Lot Numbers: 170160016S, 2/20/2017; 170240147S, 3/1/2017; 170380016S, 3/15/2017; 170450010S, 3/22/2017
Recall Number: D-0906-2017
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
02-17-2017
06-21-2017
216 bags
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
Batch or Lot Expiration Information
Lot# Lot Numbers: 70090135M, 2/27/2017; 170250101M, 3/15/2017; 170030011D, 4/4/2017; 170040078D, 4/5/2017; 170310012D, 5/2/2017; 170400046D, 5/11/2017
Recall Number: D-0914-2017
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
02-17-2017
06-21-2017
816 bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Batch or Lot Expiration Information
Lot# Lot Numbers: 170200039S, 2/22/2017; 170230182S, 170230137S, 2/23/2017; 170260122S, 2/26/2017; 170300085S, 3/2/2017; 170320048S, 3/4/2017; 170340152S, 3/8/2017; 170380097S, 3/10/2017
Recall Number: D-0909-2017
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
02-17-2017
06-21-2017
192 bags
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Batch or Lot Expiration Information
Lot# Lot Numbers: 163640146S, 3/30/2017; 170020187S, 4/3/2017; 170100120S, 4/11/2017; 170200117S, 4/23/2017; 170340009S, 5/6/2017
Recall Number: D-0911-2017
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
02-17-2017
06-21-2017
672 bags
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Batch or Lot Expiration Information
Lot# Lot Numbers: 163640076D, 3/30/2017; 170040009D, 4/5/2017; 170040224S, 4/5/2017; 170040065S, 4/5/2017; 170050068D, 4/6/2017; 170060353S, 4/9/2017; 170100076D, 4/11/2017; 170100111S, 4/11/2017; 170120090D, 4/13/2017; 170120154S, 4/13/2017; 170160150S, 4/17/2017; 170260005D, 4/27/2017; 170380110S, 5/9/2017; 170400085S, 5/11/2017
Recall Number: D-0913-2017
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
02-17-2017
06-21-2017
216 bags
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Batch or Lot Expiration Information
Lot# Lot Numbers: 163640084D, 3/30/2017; 170120081D, 4/13/2017; 170160062D, 4/17/2017; 170200066D, 4/23/2017; 170370011D, 5/8/2017
Recall Number: D-0907-2017
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
02-17-2017
06-21-2017
143 bags
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
Batch or Lot Expiration Information
Lot# Lot Numbers: 163640167M, 3/21/2017; 170050171M, 3/28/2017; 170070172M, 3/31/2017;170190235M, 4/11/2017; 170200120M, 4/14/2017; 170230115M, 4/15/2017; 170390059D, 5/10/2017
Recall Number: D-0910-2017
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
02-17-2017
06-21-2017
912 bags
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Batch or Lot Expiration Information
Lot# Lot Numbers: 170050001D, 4/5/2017; 170040025D, 4/5/2017; 170060046D, 4/9/2017; 170090062D, 4/10/2017; 170110125S, 4/12/2017; 170170016S, 4/18/2017; 170200120S, 4/23/2017; 170380108S, 5/9/2017
Recall Number: D-0912-2017
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
02-17-2017
06-21-2017
48 bags
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Batch or Lot Expiration Information
Lot# Lot Numbers: 170100124S, 4/11/2017; 170390015S, 5/10/2017
Recall Number: D-0916-2017
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
02-17-2017
06-21-2017
108 bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Batch or Lot Expiration Information
Lot# Lot Numbers: 170250124S, 2/25/2017; 170270018S, 2/28/2017; 170380015S, 3/10/2017
Recall Number: D-0908-2017
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
02-17-2017
06-21-2017
144 bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Batch or Lot Expiration Information
Lot# Lot Numbers: 170020074D, 4/3/2017; 170050071D, 4/6/2017; 170270036D, 4/30/2017
