Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04

FDA recall notice · announced June 21, 2017 · Hospira Inc., A Pfizer

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04

Reason for recall

GMP Deviation; A foreign stopper was observed during packaging of a lot of product.

Notes

Distribution: Nationwide, Canada and Singapore
Lot/code information: 720503A, 720603A (Canada only)
Quantity: (720503A): 43,200 vials, (720603A): 400 vials
Status: Terminated
Products in this recall event:
- Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04 (D-0898-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.