Recall Enforment Report D-1168-2017

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pfizer Inc., originally initiated on 08-22-2017 for the product Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04 The product was recalled due to lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.. 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-1168-2017	08-22-2017	09-27-2017	Class II	98,050 vials	Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04	Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.	Terminated
D-1167-2017	08-22-2017	09-27-2017	Class II	115,370 vials	HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)	Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0409-1283	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Injection, Solution	Intramuscular; Intravenous; Subcutaneous	Hospira, Inc.	Human Prescription Drug
0409-1283	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Injection, Solution	Intramuscular; Intravenous; Subcutaneous	Hospira, Inc.	Human Prescription Drug
0409-1304	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Injection, Solution	Intramuscular; Intravenous; Subcutaneous	Hospira, Inc.	Human Prescription Drug
0409-1312	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Injection, Solution	Intramuscular; Intravenous; Subcutaneous	Hospira, Inc.	Human Prescription Drug
0409-1312	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Injection, Solution	Intramuscular; Intravenous; Subcutaneous	Hospira, Inc.	Human Prescription Drug
0409-2552	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Injection, Solution	Intramuscular; Intravenous; Subcutaneous	Hospira, Inc.	Human Prescription Drug
0409-3365	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Injection, Solution	Intramuscular; Intravenous; Subcutaneous	Hospira, Inc.	Human Prescription Drug
0409-3375	Levophed	Norepinephrine Bitartrate	Injection, Solution, Concentrate	Intravenous	Hospira, Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	77956 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1168-2017 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	United States Nationwide (including Puerto Rico) and Singapore 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	Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04
Reason For Recall	Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	98,050 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	09-27-2017
Recall Initiation Date	08-22-2017 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	02-19-2023 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	Pfizer Inc.
Code Info	Lot #: 753003A, Exp 9/18; 762153A, 760803A, 761053A , Exp 10/18 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	0409-3375-14; 0409-3375-04; 0409-1443-14; 0409-1443-04
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	77956 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1167-2017 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	United States Nationwide (including Puerto Rico) and Singapore 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	HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)
Reason For Recall	Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	115,370 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	09-27-2017
Recall Initiation Date	08-22-2017 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	02-19-2023 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	Pfizer Inc.
Code Info	Lot: 760853A 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	0409-2552-11; 0409-2552-01; 0409-3356-11; 0409-3356-01; 0409-2540-11; 0409-2540-01; 0409-3365-11; 0409-3365-01; 0409-3365-10; 0409-1283-03; 0409-1283-31; 0409-1283-09; 0409-1283-10; 0409-1283-04; 0409-1283-05; 0409-1312-03; 0409-1312-30; 0409-1312-09; 0409-1312-10; 0409-1304-03; 0409-1304-31
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.