Recall Enforment Report D-1080-2017

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by HOSPIRA INC, LAKE FOREST, originally initiated on 07-26-2017 for the product Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01 The product was recalled due to presence of particulate matter: silicone oil. 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-1080-2017	07-26-2017	08-16-2017	Class II	14,300 vials	Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01	Presence of Particulate Matter: Silicone oil	Terminated
D-1081-2017	07-26-2017	08-16-2017	Class II	9,009 vials	Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50	Presence of Particulate Matter: Silicone oil	Terminated
D-1082-2017	07-26-2017	08-16-2017	Class II	56,340 vials	Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.	Presence of Particulate Matter: Silicone oil	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0409-2634	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Injection, Solution	Intramuscular; Intravenous; Subcutaneous	Hospira, Inc.	Human Prescription Drug
0703-0018	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Injection, Solution	Intramuscular; Intravenous; Subcutaneous	Teva Parenteral Medicines, Inc.	Human Prescription Drug
0703-0110	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Injection, Solution	Intramuscular; Intravenous; Subcutaneous	Teva Parenteral Medicines, Inc.	Human Prescription Drug
0703-0113	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Injection, Solution	Intramuscular; Intravenous; Subcutaneous	Teva Parenteral Medicines, Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	77836 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1080-2017 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 in the USA 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 Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01
Reason For Recall	Presence of Particulate Matter: Silicone oil What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	14,300 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	08-16-2017
Recall Initiation Date	07-26-2017 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	05-11-2018 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Telephone 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, LAKE FOREST
Code Info	Lot #: 560053F, Exp. 01AUG2017 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	0703-0110-01; 0703-0110-03; 0703-0113-01; 0703-0113-03; 0703-0018-01
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	77836 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1081-2017 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 in the USA 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 Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50
Reason For Recall	Presence of Particulate Matter: Silicone oil What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	9,009 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	08-16-2017
Recall Initiation Date	07-26-2017 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	05-11-2018 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Telephone 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, LAKE FOREST
Code Info	Lot #: 56260DD, Exp. 01AUG2017 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	0409-2634-10; 0409-2634-01; 0409-2634-25; 0409-2634-05; 0409-2634-50
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	77836 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1082-2017 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 in the USA 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 Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.
Reason For Recall	Presence of Particulate Matter: Silicone oil What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	56,340 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	08-16-2017
Recall Initiation Date	07-26-2017 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	05-11-2018 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Telephone 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, LAKE FOREST
Code Info	Lot #: 560103F, Exp. 01AUG2017 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	0703-0110-01; 0703-0110-03; 0703-0113-01; 0703-0113-03; 0703-0018-01
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.