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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 65077
Product Type Drugs
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-26
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot 05-585-EV Exp. 05/13 Class II Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. 114,000 vials D-313-2013
Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04 Lot 20-564-DK Exp. 02/14 Class II Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. 259,050 vials D-314-2013
QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02 Lot 21-480-EV Exp.12/13 Class II Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. 139,200 vials D-315-2013
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73 Lot 23-320-DK and 23-321-DK Exp. 11/14 Class II Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. 266,900 vials D-316-2013
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