D-0254-2015 Class III Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA drug recall D-0254-2015 was initiated by Hospira Inc. on Nov 7, 2014 and is designated Class III. Reason for recall: Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product. The recall status is terminated (terminated Mar 22, 2017). Affected quantity: 316,640 vials.

Recall Details

Product Type
Drugs
Report Date
Nov 26, 2014
Initiation Date
Nov 7, 2014
Termination Date
Mar 22, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
316,640 vials

Product Description

Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01.

Reason for Recall

Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.

Distribution Pattern

Nationwide.

Code Information

Lot# 43-240-DD; Exp. 07/16 Lot# 44-205-DD,44-455-DD,44-460-DD,44-465-DD; Exp. 08/16

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0254-2015
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.