September 6, 2017

FDA: Recall of Hydromorphone HCL and Levophed Injection by Hospira

By: Judy Mathias
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Editor’s Note

The Food and Drug Administration (FDA) on September 5 announced the recall by Hospira Inc (Lake Forest, Illinois) of one lot of Hydromorphone HCL injection, USP, CII 2 mg/mL and four lots of Levophed (norepinephrine bitartrate) injection because of a lack of sterility assurance resulting from a damaged sterilizing filter for nitrogen used in the manufacturing process.

To date, Hospira has not received reports of any adverse events associated with this issue for these lots.

 

Posted 09/05/2017] AUDIENCE: Pharmacy ISSUE: Hospira is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII 2 mg/mL and four lots of Levophed (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

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