Recall Enforment Report D-0597-2018

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Pfizer Inc., originally initiated on 02-07-2018 for the product Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01 The product was recalled due to non-sterility: confirmed customer complaints of glass product container vials that may be empty or cracked.. 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-0597-2018	02-07-2018	03-21-2018	Class I	29, 680 vials	Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01	Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.	Terminated
D-0596-2018	02-07-2018	03-21-2018	Class I	53600 vials	Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01	Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.	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	79114 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0597-2018 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 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 CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
Reason For Recall	Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	29, 680 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	03-21-2018
Recall Initiation Date	02-07-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	08-07-2019 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	Pfizer Inc.
Code Info	Lot 71330DD EXP. 11/1/2018. 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	79114 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0596-2018 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 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 CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01
Reason For Recall	Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	53600 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	03-21-2018
Recall Initiation Date	02-07-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	08-07-2019 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	Pfizer Inc.
Code Info	Lots # 691853F, EXP. 9/1/2018; 700753F, EXP. 10/1/2018. 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.