Safety

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Pharmedium Issues Voluntary Nationwide Recall of 4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag for Discoloration.

For Immediate Release

December 31, 2015

Contact

Consumers

Thomas Rasnic
847-457-2256

Announcement

Lake Forest, IL PharMEDium Services, LLC is voluntarily recalling 29 lots of 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 3 lots of 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag distributed to hospital customers. We have received complaints from hospitals for products that have been found to exhibit a slight discoloration in the admixture. The drug manufacturer's prescribing information advises not to use the product if it is discolored.

Discoloration is indicative of degradation and could result in decreased potency due to oxidation of Norepinephrine Bitartrate. Decreased potency may result in a delay of achieving desired therapeutic effect. PharMEDium Services has not received any reports of adverse events to date related to this recall.

The product is used for blood pressure control in certain acute hypotensive states and is packaged in a 250 mL Viaflex Bag. The affected 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag include the following lot numbers and expiration dates:

2K6134
Lot#Expiration Date
15342084S2/10/2016
15342191S2/10/2016
15342223S2/10/2016
15342224S2/10/2016
15342225S2/10/2016
15342226S2/10/2016
15343025S2/11/2016
15343026S2/11/2016
15343129S2/11/2016
15343131S2/11/2016
15344157S2/12/2016
15344160S2/12/2016
15344209S2/12/2016
15345036S2/13/2016
15345104S2/13/2016
15345106S2/13/2016
15345142S2/13/2016
15346015S2/14/2016
15346016S2/14/2016
15346017S2/14/2016
15346018S2/14/2016
15346019S2/14/2016
15346020S2/14/2016
15346022S2/14/2016
15346023S2/14/2016
15348152S2/16/2016
15348197S2/16/2016
15350046S2/18/2016
15350154S2/18/2016
2K6127
Lot#Expiration Date
15342123S2/10/2016
15349071S2/10/2016
15351050S2/10/2016

The product can be identified by PharMEDium Services Code 2K6134 (NDC Number 61553-134-61) 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag or 2K6127 (NDC 61553-127-61) 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag

On December 22, 2015, PharMEDium Services e-mailed notification to all affected customers and requested quarantine and destruction. Replacement of all recalled products is available.

Hospital pharmacies that have the recalled 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag in stock should stop using and discard per the hospital destruction policy. Hospitals that may have shared these products with other hospitals should contact those hospitals that received the products.

Hospitals or other healthcare providers with questions regarding this recall can contact PharMEDium Services by calling 847-457-2244 or email at quality1@pharmedium.com Monday through Friday, 8:00 AM to 5:00 PM, Central Standard Time. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

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Product Photos

  • Label-4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag
  • Label-8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag

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