Home / Recalls / Hospira Inc., A Pfizer Company / D-0898-2017

D-0898-2017 Class II Terminated

Recalled by Hospira Inc., A Pfizer Company — Lake Forest, IL

FDA drug recall D-0898-2017 was initiated by Hospira Inc., A Pfizer Company on May 18, 2017 and is designated Class II. Reason for recall: GMP Deviation; A foreign stopper was observed during packaging of a lot of product. The recall status is terminated (terminated May 2, 2019). Affected quantity: (720503A): 43,200 vials, (720603A): 400 vials.

Recall details

Product Type: Drugs
Report Date: Jun 21, 2017
Initiation Date: May 18, 2017
Termination Date: May 2, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: (720503A): 43,200 vials, (720603A): 400 vials

Product description

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.

Distribution pattern

Nationwide, Canada and Singapore

Code information

720503A, 720603A (Canada only)

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0898-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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