Recall Enforment Report D-1161-2014

Recall Details

Drug Recall Enforcement Report Class I voluntary initiated by Hospira Inc., originally initiated on 10-18-2013 for the product Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30. The product was recalled due to presence of particulate matter: units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.. The product was distributed nationwide and the recall is currently terminated.

Field Name Field Value
Event ID 66503 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-1161-2014 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Reason For Recall Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 40,360 vials Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 03-26-2014
Recall Initiation Date 10-18-2013 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 12-18-2015 What is the Date Terminated?
The date that FDA terminated the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Hospira Inc.
Code Info Lot 25-220-DD, Exp 1JAN2015 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 0409-1559-18; 0409-1559-10; 0409-1559-19; 0409-1559-30; 0409-1560-18; 0409-1560-10; 0409-1560-19; 0409-1560-29; 0409-1582-18; 0409-1582-10; 0409-1582-19; 0409-1582-29; 0409-1587-50; 0409-1610-50; 0409-1746-70; 0409-1746-10; 0409-1746-71; 0409-1746-30; 0409-1749-70; 0409-1749-10; 0409-1749-71; 0409-1749-29; 0409-1752-50; 0409-1755-50
Status Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0409-1559Marcaine Bupivacaine HydrochlorideInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-1560Marcaine Bupivacaine HydrochlorideInjection, SolutionEpidural; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-1582Marcaine Bupivacaine HydrochlorideInjection, SolutionEpidural; RetrobulbarHospira, Inc.Human Prescription Drug
0409-1587Marcaine Bupivacaine HydrochlorideInjection, SolutionInfiltration; PerineuralHospira, Inc.Human Prescription Drug
0409-1610Marcaine Bupivacaine HydrochlorideInjection, SolutionPerineuralHospira, Inc.Human Prescription Drug
0409-1746Marcaine With Epinephrine Bupivacaine Hydrochloride And Epinephrine BitartrateInjection, SolutionEpidural; Infiltration; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-1749Marcaine With Epinephrine Bupivacaine Hydrochloride And Epinephrine BitartrateInjection, SolutionEpidural; Intracaudal; PerineuralHospira, Inc.Human Prescription Drug
0409-1752Marcaine With Epinephrine Bupivacaine Hydrochloride And Epinephrine BitartrateInjection, SolutionInfiltration; PerineuralHospira, Inc.Human Prescription Drug
0409-1755Marcaine With Epinephrine Bupivacaine Hydrochloride And Epinephrine BitartrateInjection, SolutionPerineuralHospira, Inc.Human Prescription Drug