Discolored Compounds Subject to Recall from PharMEDium Services

Discolored Compounds Subject to Recall from PharMEDium Services
Image: Pixabay
January 4, 2016

A pharmaceutical compounding company is issuing a recall for certain products due to discoloration.

PharMEDium Services, LLC is voluntarily recalling 29 lots of 4mg Norepinephrine Bitartrate and three lots of 8mg Norepinephrine Bitartrate. The lots were sold to hospitals and were intended to be added to 0.9 percent Sodium Chloride in 250mL Viaflex Bag. The product is used for blood pressure control in certain acute hypotensive states.

PharMEDium has received multiple complaints from hospitals of a slight discoloration in the admixture. No reports of adverse events have been recorded. For a list of the affected lot numbers and expiration dates, see the Food and Drug Administration (FDA) release.

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 has emailed notification to all affected customers and requested quarantine and destruction. Replacements will be made available.

Hospitals or other healthcare providers with questions about this recall can contact PharMEDium Services by phone at (847) 457-2244 or by email at quality1@pharmedium.com.