Recall Enforment Report D-0097-2017

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Hospira Inc., A Pfizer Company, originally initiated on 09-16-2016 for the product Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50. The product was recalled due to lack of assurance of sterility and subpotent drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0097-2017	09-16-2016	10-19-2016	Class II	4768 vials	Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.	Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.	Terminated
D-0096-2017	09-16-2016	10-19-2016	Class II	15 vials	Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.	Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0409-1559	Marcaine	Bupivacaine Hydrochloride	Injection, Solution	Epidural; Infiltration; Intracaudal; Perineural	Hospira, Inc.	Human Prescription Drug
0409-1560	Marcaine	Bupivacaine Hydrochloride	Injection, Solution	Epidural; Intracaudal; Perineural	Hospira, Inc.	Human Prescription Drug
0409-1582	Marcaine	Bupivacaine Hydrochloride	Injection, Solution	Epidural; Retrobulbar	Hospira, Inc.	Human Prescription Drug
0409-1587	Marcaine	Bupivacaine Hydrochloride	Injection, Solution	Infiltration; Perineural	Hospira, Inc.	Human Prescription Drug
0409-1610	Marcaine	Bupivacaine Hydrochloride	Injection, Solution	Perineural	Hospira, Inc.	Human Prescription Drug
0409-1746	Marcaine With Epinephrine	Bupivacaine Hydrochloride And Epinephrine Bitartrate	Injection, Solution	Epidural; Infiltration; Intracaudal; Perineural	Hospira, Inc.	Human Prescription Drug
0409-1749	Marcaine With Epinephrine	Bupivacaine Hydrochloride And Epinephrine Bitartrate	Injection, Solution	Epidural; Intracaudal; Perineural	Hospira, Inc.	Human Prescription Drug
0409-1752	Marcaine With Epinephrine	Bupivacaine Hydrochloride And Epinephrine Bitartrate	Injection, Solution	Infiltration; Perineural	Hospira, Inc.	Human Prescription Drug
0409-1755	Marcaine With Epinephrine	Bupivacaine Hydrochloride And Epinephrine Bitartrate	Injection, Solution	Perineural	Hospira, Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	75156 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0097-2017 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote 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 and Puerto Rico 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 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
Reason For Recall	Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	4768 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	10-19-2016
Recall Initiation Date	09-16-2016 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	07-31-2019 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., A Pfizer Company
Code Info	Lot #: 59310DD, Exp 1NOV2017 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.

Field Name	Field Value
Event ID	75156 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0096-2017 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote 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 and Puerto Rico 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 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.
Reason For Recall	Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	15 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	10-19-2016
Recall Initiation Date	09-16-2016 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	07-31-2019 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., A Pfizer Company
Code Info	Lot #: 60295DD, Ep 1DEC2017 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.