Skip to Content

hydromorphone FDA Alerts

The FDA Alert(s) below may be specifically about hydromorphone or relate to a group or class of drugs which include hydromorphone.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for hydromorphone

PharMEDium Services, LLC Issues Voluntary Nationwide Recall of 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe Due to Presence of Sulfite

Jun 28, 2019

Audience: Consumer, Health Professional, Pharmacy

June 28, 2019 -- PharMEDium Services, LLC is voluntarily recalling 45 lots of 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe to the user level. The product is being recalled because PharMEDium’s electronic customer ordering system stated it is sulfite-free, but the product contains sulfite.

Risk Statement:

Serious adverse reactions could occur in patients with a sulfite allergy who are exposed to Hydromorphone containing sulfites. The reactions may range from mild wheezing to severe bronchospasm and anaphylaxis. To date, PharMEDium Services, LLC has not received any adverse event reports related to sulfite reactions or sensitivity.

The product is used for relief of moderate to severe pain in opioid tolerant patients and is packaged as 1 mL in 3 mL BD Syringe, in packages of 5 syringes, NDC # 61553-352-78. 28,140 syringes were distributed to a total of 6 customers in the USA. The complete list of affected HYDROmorphone HCl is included in the table below which contains the product description, lot number, expiration date and NDC.

Service Code Service Code Description Lot Number Expiration Date NDC
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190670030D 06/09/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190670031D 06/09/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190670032D 06/09/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190670033D 06/09/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190710015D 06/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190710016D 06/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190710017D 06/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190710018D 06/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190710019D 06/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190730028D 06/13/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190730029D 06/13/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190730030D 06/13/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190740018D 06/16/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190770028D 06/17/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190770029D 06/17/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190780027D 06/18/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190780028D 06/18/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190780029D 06/18/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190790030D 06/19/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190800012D 06/20/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190800013D 06/20/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190800015D 06/20/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190800016D 06/20/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190810033D 06/23/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190810034D 06/23/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190810035D 06/23/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190810036D 06/23/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190840002D 06/24/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190870008D 06/27/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190910015D 07/01/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190980033D 07/08/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190990017D 07/09/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190990030D 07/09/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191000035D 07/10/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191010008D 07/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% 191010009D 07/11/2019 61553-352-78
  Sodium Chloride 1 mL in 3 mL BD Syringe      
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191010010D 07/11/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191050002D 07/15/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191120002D 07/22/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191160001D 07/28/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 190800014D 06/20/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191210020D 07/31/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191210021D 07/31/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191210022D 07/31/2019 61553-352-78
2R3352-5 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe 191220017D 08/01/2019 61553-352-78

The product can be identified by referring to the sample label included with this release.

PharMEDium Services, LLC has notified all six customers by email/phone and has arranged for replacement orders of all recalled products. All six customers have been advised to identify, quarantine and destroy any remaining product according to their facilities policies and procedures and to notify PharMEDium Services, LLC of the units requiring credit. Customers have been notified to 100% effectiveness and all six customers have responded with the number of syringes for credit. They have been instructed on how to receive replacement orders.

Consumers with questions regarding this recall can contact PharMEDium Services, LLC by dialing 800-523- 7749 (8:00 am – 5:00 pm Central Time) or Quality1@pharmedium.com by email. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

Nov 14, 2018

Audience: Patient, Caregiver, Health Professional, Pain Management, Pharmacy, Neurology, Surgery

ISSUE: The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump. While individual patients may experience some relief from using pain medicines not approved for intrathecal administration in their implanted pumps, such use may create additional risks including dosing errors, pump failures, and other safety concerns. The FDA wants to ensure that patients, caregivers, compounders, pharmacists, and health care providers are aware of these risks to make informed treatment decisions.

BACKGROUND: Implanted pumps are medical devices that are surgically implanted under the skin, typically in the abdomen. They are connected to an implanted catheter and are used to deliver prescription medicines and fluids within the body, including the intrathecal space (into the spinal fluid), to treat pain, muscle spasticity, and other diseases or conditions. Implanted pumps are periodically refilled with medicines or fluids by a health care provider.

They are often used to treat or manage pain after other treatments, such as oral medicines, physical therapy, or surgery, are unsuccessful.

The FDA-approved implanted pump labeling identifies which pain medicines are approved for use with each pump. Pain medicines approved by FDA for delivery into the spinal fluid must meet additional safety standards because the spinal cord and brain tissue are highly sensitive to preservatives or infectious organisms such as bacteria or viruses. The implanted pump’s current labeling should be reviewed to determine which pain medicines are approved for use in each pump. The table below includes examples of medicines approved and not approved for intrathecal use with implanted pumps to treat or manage pain.

RECOMMENDATION: When considering a medicine for use in an implanted pump:

  1. Review the implanted pump labeling to identify the medicines and medicine concentrations approved for use with that specific pump.

  2. Be aware that the following medicines are NOT currently approved for use with implanted pumps for intrathecal infusion of pain medications:

    • Medicines not FDA approved for intrathecal administration or intrathecal implanted pump use (for example, hydromorphone, bupivacaine, fentanyl, clonidine)

    • Any mixture of two or more different kinds of medicines

    • Any compounded medicine (for example, to achieve higher concentration or different formulation of an FDA approved medicine)

  3. Be aware that while individual patients may experience some relief from using medicines not approved for intrathecal administration in their implanted pumps for pain management, such use may pose additional risks including pump failures, dosing errors, and other potential safety issues.

  4. Health care providers, patients, and caregivers are encouraged to consider and discuss both the benefits and risks of using implanted pumps for the intrathecal infusion of medications for pain management in order to make informed treatment decisions.

  5. Report adverse events to the FDA if you suspect an implanted pump is having problems:

    • User facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

    • Health care providers employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

  • Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/14/2018 - Medical Device Safety Communication - FDA]

 

Hydromorphone HCL Injection USP by Hospira: Recall - Potential For Empty Or Cracked Glass Vials

Mar 5, 2018

Audience: Pharmacy, Risk Manager

ISSUE: Hospira is voluntarily recalling three lots of Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 – Teva lots) to the hospital/institution level. Hospira initiated this recall on February 07, 2018 due to the potential that units from these lots may be empty or cracked at the bottom of the glass vial.

Cracked vials may compromise the sterility of the product. Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals. Intravenous infusion of a non-sterile solution can lead to bloodstream infections, which may potentially lead to bacteremia or sepsis. These infections are of concern especially to immunocompromised patients.

BACKGROUND: Hydromorphone HCl is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is also indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials, is packaged in a carton of 10 x 1 mL Single-dose vials. The affected lots include the following NDC, lot numbers and expiry dates. Product was distributed nationwide to wholesalers/distributors/retailers/hospitals in the United States and Puerto Rico from October 2016 to July 2017.

RECOMMENDATION: Hospira, Inc. has notified wholesalers/ distributors/retailers/hospitals by recall letter to arrange for return of any recalled product. Wholesalers/distributors/retailers/hospitals with an existing inventory of the lots subject to this recall should stop use and distribution of the remaining units and quarantine immediately. Healthcare Professionals in your organization should be informed of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[03/05/2018 - Press Release - Hospira]

Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination

Oct 21, 2017

Audience: Pharmacy, Health Professional

ISSUE: SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. There is a potential for the products to contain microbial contamination.  See the recall notice for a full list of products.

BACKGROUND: Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. SCA Pharmaceuticals has not received any customer complaints or reports of adverse events related to this issue.

RECOMMENDATION: SCA Pharmaceuticals is notifying its customers via telephone, email and US mail and is arranging for return/replacement of all recalled products. Customers that have product which is being recalled, as indicated in the list above, should discontinue use immediately and return the product to SCA Pharmaceuticals.

Consumers with questions regarding this recall can contact SCA Pharmaceuticals at 877-550-5059, between the hours of 8:00 am and 5:00 pm (Central Standard Time), Monday thru Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[10/20/2017 - Recall Notice - SCA Pharmaceuticals]

Hydromorphone HCl Injection, USP 2 mg/mL, and Levophed (Norepinephrine Bitartrate Injection, USP) 4 mg/4 mL (1 mg/mL) Vial by Hospira: Recall - Lack of Sterility Assurance

Sep 5, 2017

Audience: Pharmacy

ISSUE: Hospira is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII 2 mg/mL and four lots of Levophed (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

The possibility of a breach in sterility assurance in distributed product, while not confirmed, cannot be eliminated.  No batches of product have been identified as containing microorganisms. To date, Hospira has not received reports of any adverse events associated with this issue for these lots. See the press release for lot numbers recalled. 

In the event that impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur.

BACKGROUND: Hydromorphone Hydrochloride Injection, USP, CII is indicated for the relief of moderate to severe pain. Levophed (Norepinephrine Bitartrate Injection, USP) is indicated in adults for blood pressure control in certain acute hypotensive states.

RECOMMENDATION: Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital level.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[08/31/2017 - Press Release - Hospira]

Hospira Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject: Recall- May Contain More Than The Intended Fill Volume

Aug 16, 2012

Audience: Risk Manager, Pharmacy

Issue: Hospira and FDA notified healthcare professional of a nationwide voluntraty recall of one lot of Hydromorphone Injection, USP, 2 mg/mL, (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1312-30, due to a reported complaint of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), low blood pressure and reduced heart rate including circulatory collapse.

Background:  The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 12720LL. The expiration date is December 1, 2013 and was distributed in March – May 2012.  Hospira has not received any reports of adverse events related to this issue for this lot.

Recommendations: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-866-873-0312 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.

For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[08/15/2012 - Firm Press Release - Hospira] 

[05/23/2012 - Hospira Carpuject Drug Alert - FDA]

[05/14/2012 - Hydromorphone Hydrochloride Injection Recall

 

Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume

May 14, 2012

Audience: Risk Manager, Consumer

ISSUE: Hospira, Inc. notified healthcare professionals of a recall of one lot of Hydromorphone Hydrochloride Injection 1 MG/ML, due to reports of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.

The affected lot number is 07547LL, with an expiration date of July 1, 2013. The affected lot was distributed in September – October 2011. It was initially distributed to wholesalers and a limited number of hospitals in Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin.

BACKGROUND: The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[05/12/2012 - Press Release - Hospira, Inc.]

Ethex Corporation Product Recall

Jan 28, 2009

Audience: Pharmacists, Consumers

[Posted 01/27/2009] FDA notified pharmacists and consumers that ETHEX Corporation has expanded two previous 2008 recalls to include over 60 generic drug products recalled to wholesalers, and two generic drug products, Hydromorphone HCl and Metoprolol Succinate, recalled to retailer level. These generic products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

[January 28, 2009 - Press Release - Ethex]

Hydromorphone HCl 2 mg Tablets

Dec 24, 2008

Audience: Pharmacists, consumers, primary care healthcare professionals

[Posted 12/24/2008] ETHEX and FDA notified heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets. Hydromorphone is a drug used for pain management. If someone were to take a higher than expected dose of Hydromorphone, the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation. The recalled tablets are a blue, round tablet with a script "E" on one side and a "2" on the other side.

The parent company of ETHEX Corporation, KV Pharmaceutical has advised FDA that it is voluntarily suspending shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to address manufacturing issues that have come to management’s attention. See the link below for a list of tablets affected by suspended shipments.

[December 23, 2008 - Press Release - Ethex]
[December 23, 2008 - Press Release - KV]
[December 23, 2008 - Tablets Affected by Suspended Shipments - KV]

Injectable drugs prepared by Urgent Care Pharmacy

Nov 18, 2002

Audience: All healthcare professionals

The Food and Drug Administration (FDA) announced a nationwide alert concerning all injectable drugs prepared by Urgent Care Pharmacy of Spartanburg, South Carolina, based on the lack of assurance that their products are sterile. Non-sterility of injectable products can represent a serious hazard to health that could lead to life-threatening injuries and death. FDA inspection of Urgent Care's facility revealed the firm failed to have adequate controls to ensure necessary sterility, including the absence of appropriate testing for potency and sterility prior to distribution.

FDA is aware that Urgent Care has distributed the following injectable drugs to physicians, hospitals, clinics and consumers in Connecticut, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, North Carolina, South Carolina and Virginia: Baclofen, Betamethasone, Bimix 30:1, (Phentolamine mesylate/papaverine), Clonidine, Estradiol, Hydromorphone HCl, Fentanyl, methylprednisolone acetate, Morphine Sulfate/Bupivacaine, Papaverine HCl, Super Trimix (Papaverine HCl/phentolamine mesylate/prostaglandin), Testosterone cypionate, Testosterone/Estradiol.

[November 15, 2002 Talk Paper - FDA]

More hydromorphone Resources