Multi-event December 2019 FDA Recall Drug by Pharmedium Services, Llc

This Multi-event Class III drug recall was voluntarily initiated by Pharmedium Services, Llc on December 16, 2019 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0625-2020 TERMINATED D-0627-2020 TERMINATED D-0626-2020 TERMINATED

Recall Number: D-0625-2020

Reason for Recall
Subpotent Drug
Initiated
12-16-2019
Reported
01-01-2020
Quantity
5820 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84525
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-09-2021
Product Description About Product Description
Full technical description of the product.
NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.

Batch or Lot Expiration Information

Lot# s: 192930039S Exp. 12/18/19; 192930041S Exp. 12/18/19; 192940048S Exp. 12/19/19; 192940049S Exp. 12/19/19; 192950031S Exp. 12/20/19; 192950032S Exp. 12/20/19; 192960039S Exp. 12/22/19; 192960040S Exp. 12/22/19; 192960041S Exp. 12/22/19; 192960042S Exp. 12/22/19; 192970034S Exp. 12/22/19; 192970036S Exp. 12/22/19; 192970037S Exp. 12/22/19; 192980043S Exp. 12/25/19; 192980044S Exp. 12/25/19; 192980045S Exp. 12/25/19; 193010042S Exp. 12/26/19; 193020042S Exp. 12/27/19; 193030039S Exp. 12/28/19; 193030040S Exp. 12/28/19; 193030049S Exp. 12/28/19; 193040045S Exp. 12/29/19; 193040046S Exp. 12/29/19; 193040047S Exp. 12/29/19; 193080040S Exp. 1/2/20; 193080041S Exp. 1/2/20; 193080042S Exp. 1/2/20; 193080043S Exp. 1/2/20; 193080044S Exp. 1/2/20; 193090034S Exp. 1/3/20; 193090035S Exp. 1/3/20; 193090036S Exp. 1/3/20; 193100041S Exp. 1/4/20; 193100042S Exp. 1/4/20; 193100043S Exp. 1/4/20; 193120036S Exp. 1/8/20; 193150028S Exp. 1/9/20; 193170033S Exp. 1/11/20; 193170034S Exp. 1/11/20; 193170035S Exp. 1/11/20; 193180035S Exp. 1/12/20; 193190035S Exp. 1/15/20; 193190038S Exp. 1/15/20; 193220038S Exp. 1/16/20; 193230037S Exp. 1/17/20; 193240029S Exp. 1/18/20; 193240030S Exp. 1/18/20; 193240031S Exp. 1/18/20; 193250028S Exp. 1/19/20; 193360031S Exp. 1/30/20

Recall Number: D-0627-2020

Reason for Recall
Subpotent Drug
Initiated
12-16-2019
Reported
01-01-2020
Quantity
5808 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84525
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-09-2021
Product Description About Product Description
Full technical description of the product.
NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.

Batch or Lot Expiration Information

Lot# Lots: 192930026S Exp. 12/18/19; 192950020S Exp. 12/20/19; 192960029S Exp. 12/21/19; 192970024S Exp. 12/22/19; 193010034S Exp. 12/26/19; 193030036S Exp. 12/28/19; 193040029S Exp. 12/29/19; 193050030S Exp. 1/1/20; 193080025S Exp. 1/2/20; 193080026S Exp. 1/2/20; 193080027S Exp. 1/2/20; 193090017S Exp. 1/3/20; 193090018S Exp. 1/3/20; 193100032S Exp. 1/4/20; 193120028S Exp. 1/8/20; 193160027S Exp. 1/10/20; 193170024S Exp. 1/11/20; 193170025S Exp. 1/11/20; 193180026S Exp. 1/12/20; 193190031S Exp. 1/15/20; 193230027S Exp. 1/17/20; 193240015S Exp. 1/18/20; 193240016S Exp. 1/18/20; 193240017S Exp. 1/18/20; 193240018S Exp. 1/18/20; 193250017S Exp. 1/19/20

Recall Number: D-0626-2020

Reason for Recall
Subpotent Drug
Initiated
12-16-2019
Reported
01-01-2020
Quantity
864 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84525
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-09-2021
Product Description About Product Description
Full technical description of the product.
NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.

Batch or Lot Expiration Information

Lot# s: 193040035S, Exp. 12/29/2019; 193120031S, Exp. 01/08/2020; 193150024S, Exp. 01/09/20; 193180030S, Exp. 01/12/20; 193240028S, Exp. 01/18/20; 193250022S, Exp. 01/19/20.