FDA Recall D-0727-2016

Hospira Inc. · Lake Forest, IL

Class III Ongoing 3754 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.

Lot / code: Lot #: 56-853-FW, Exp 01AUG2017

Quantity: 10,778 bags

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".

Recall record

Recall number: D-0727-2016
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide and Hong Kong
Recall initiated: 2016-02-02
Classified by FDA Center: 2016-02-24
FDA published: 2016-03-02
Recalling firm: Hospira Inc.
Firm location: Lake Forest, IL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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