Home / Recalls / Hospira Inc., A Pfizer Company / D-0638-2017

D-0638-2017 Class I Terminated

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

FDA drug recall D-0638-2017 was initiated by Hospira Inc., A Pfizer Company on Jan 24, 2017 and is designated Class I. Reason for recall: Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product. The recall status is terminated (terminated Apr 26, 2018). Affected quantity: 30,880 vials.

Recall details

Product Type: Drugs
Report Date: Apr 12, 2017
Initiation Date: Jan 24, 2017
Termination Date: Apr 26, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 30,880 vials

Product description

Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01

Reason for recall

Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.

Distribution pattern

U.S. Nationwide

Code information

Lot # 591053A, Exp 11/1/2017

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0638-2017
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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