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. The FDA has 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:
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2K6134
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Lot#
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Expiration Date
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15342084S
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2/10/2016
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15342191S
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2/10/2016
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15342223S
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2/10/2016
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15342224S
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2/10/2016
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15342225S
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2/10/2016
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15342226S
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2/10/2016
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15343025S
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2/11/2016
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15343026S
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2/11/2016
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15343129S
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2/11/2016
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15343131S
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2/11/2016
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15344157S
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2/12/2016
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15344160S
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2/12/2016
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15344209S
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2/12/2016
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15345036S
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2/13/2016
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15345104S
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2/13/2016
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15345106S
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2/13/2016
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15345142S
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2/13/2016
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15346015S
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2/14/2016
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15346016S
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2/14/2016
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15346017S
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2/14/2016
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15346018S
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2/14/2016
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|
15346019S
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2/14/2016
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15346020S
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2/14/2016
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15346022S
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2/14/2016
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15346023S
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2/14/2016
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15348152S
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2/16/2016
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15348197S
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2/16/2016
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15350046S
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2/18/2016
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15350154S
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2/18/2016
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2K6127
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Lot#
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Expiration Date
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15342123S
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2/10/2016
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15349071S
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2/10/2016
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15351050S
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2/10/2016
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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 [email protected] 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.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.