Hydromorphone Hydrochloride Injection, Solution
FDA Recall NDC 0703-0113

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 4 recorded enforcement report(s) associated with Hydromorphone Hydrochloride (NDC 0703-0113). A significant event, classified as Class I, was initiated on Feb 07, 2018 by Teva Parenteral Medicines, Inc.. The reported reason for this action was: "Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked."

This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-0596-2018TERMINATEDD-1080-2017TERMINATEDD-1082-2017TERMINATEDD-0044-2015TERMINATED

February 2018 Class I Recall: Non-Sterility

Recall Number
D-0596-2018
Class I Terminated
Reason for Recall
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Initiated
Feb 07, 2018
Reported
Mar 21, 2018
Quantity
53600 vials

Recall Profile & Regulatory Data

Event ID
79114
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Aug 07, 2019
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
Batch or Lot Expiration Information
Lot# Lots # 691853F, EXP. 9/1/2018; 700753F, EXP. 10/1/2018.
Affected Packages Involved in this Recall
0703-0110-01Product
0703-0110-03Product
0703-0113-01Product
0703-0113-03Product
0703-0018-01Product

July 2017 Class II Recall: Presence of Particulate Matter

Recall Number
D-1080-2017
Class II Terminated
Reason for Recall
Presence of Particulate Matter: Silicone oil
Initiated
Jul 26, 2017
Reported
Aug 16, 2017
Quantity
14,300 vials

Recall Profile & Regulatory Data

Event ID
77836
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
HOSPIRA INC, LAKE FOREST
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
May 11, 2018
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
Batch or Lot Expiration Information
Lot# : 560053F, Exp. 01AUG2017
Affected Packages Involved in this Recall
0703-0110-01Product
0703-0110-03Product
0703-0113-01Product
0703-0113-03Product
0703-0018-01Product

July 2017 Class II Recall: Presence of Particulate Matter

Recall Number
D-1082-2017
Class II Terminated
Reason for Recall
Presence of Particulate Matter: Silicone oil
Initiated
Jul 26, 2017
Reported
Aug 16, 2017
Quantity
56,340 vials

Recall Profile & Regulatory Data

Event ID
77836
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
HOSPIRA INC, LAKE FOREST
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
May 11, 2018
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.
Batch or Lot Expiration Information
Lot# : 560103F, Exp. 01AUG2017
Affected Packages Involved in this Recall
0703-0110-01Product
0703-0110-03Product
0703-0113-01Product
0703-0113-03Product
0703-0018-01Product

October 2014 Class II Recall: Lack Of Assurance Of Sterility

Recall Number
D-0044-2015
Class II Terminated
Reason for Recall
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Initiated
Oct 01, 2014
Reported
Oct 29, 2014
Quantity
145,600 vials

Recall Profile & Regulatory Data

Event ID
69314
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 23, 2017
Product Description
Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL 60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL 60045.
Batch or Lot Expiration Information
Lot# : a) 260753F, 261403F, Exp 1FEB2015; 290153F, Exp 1MAY2015; b) 24-080-DD, Exp 1DEC2014; 25-475-DD, Exp 1JAN2015
Affected Packages Involved in this Recall
0703-0110-01Product
0703-0110-03Product
0703-0113-01Product
0703-0113-03Product
0703-0018-01Product
0409-2634-10Product
0409-2634-01Product
0409-2634-25Product
0409-2634-05Product
0409-2634-50Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.