Home / Recalls / Hospira Inc. / D-313-2013

D-313-2013 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA drug recall D-313-2013 was initiated by Hospira Inc. on Feb 26, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. The recall status is terminated (terminated Nov 10, 2014). Affected quantity: 114,000 vials.

Recall Details

Product Type: Drugs
Report Date: May 15, 2013
Initiation Date: Feb 26, 2013
Termination Date: Nov 10, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 114,000 vials

Product Description

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

Reason for Recall

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot 05-585-EV Exp. 05/13

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-313-2013
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

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

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