Government Resource Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors. Citation Text: US Food and Drug Administration; FDA. Copy Citation Save Save to your library Print Share Facebook Twitter Linkedin Copy URL October 10, 2018 US Food and Drug Administration; FDA. Confusing labeling can affect safe medication preparation and administration. This safety announcement reviews case reports associated with inconsistent drug strength information that contributed to dosing errors of compounded injectable products. Free full text Save Save to your library Print Share Facebook Twitter Linkedin Copy URL Cite Citation Citation Text: US Food and Drug Administration; FDA. Copy Citation Related Resources From the Same Author(s) FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration. 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FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration. April 8, 2020
Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip). June 22, 2011
FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients. March 11, 2015
Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning. March 4, 2015
FDA Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved. January 13, 2016
Information for healthcare professionals: risk of transmission of blood-borne pathogens from shared use of insulin pens. April 8, 2009
Important information for the safe use of Tussionex Pennkinetic Extended-Release Suspension. March 26, 2008
Benzocaine sprays marketed under different names, including Hurricaine, Topex, and Cetacaine. February 22, 2006
FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam). June 3, 2015
New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients. September 29, 2010
Serious medication errors from intravenous administration of nimodipine oral capsules. August 11, 2010
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products. January 13, 2021
Best Practices in Developing Proprietary Names for Human Prescription Drug Products Guidance for Industry. December 23, 2020
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: Guidance for Industry. May 25, 2022
Medication Safety During the COVID-19 Pandemic: What Have We Learned in the United States. June 23, 2020
Safety Considerations for Product Design to Minimize Medication Errors: Guidance for Industry. January 9, 2013
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. June 2, 2021
Using ventilator splitters during the COVID-19 pandemic--letter to health care providers. February 17, 2021
Computerized Prescriber Order Entry Medication Safety (CPOEMS): Uncovering and Learning From Issues and Errors. January 13, 2016
Safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications. March 4, 2015
Heparin-containing medical devices and combination products: recommendations for labeling and safety testing. Draft guidance for industry and Food and Drug Administration staff. August 5, 2015
FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder. August 5, 2020
Apotex Corp. issues voluntary nationwide recall of Enoxaparin Sodium Injection, USP due to mislabeling of syringe barrel measurement markings. February 17, 2021
Meitheal Pharmaceuticals, Inc. issues voluntary nationwide recall of Cisatracurium Besylate Injection, USP 10mg per 5mL due to mislabeling. February 10, 2021
FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only. February 3, 2021
Hospira issues a voluntary nationwide recall for one lot of 0.5% Bupivacaine Hydrochloride Injection, USP and one lot of 1% Lidocaine HCl Injection, USP due to mislabeling. May 19, 2021
Potential for medication overdose with ENFit low dose tip syringe: FDA Safety Communication. October 20, 2021
Potential for false positive results with antigen tests for rapid detection of SARS-CoV-2--letter to clinical laboratory staff and health care providers. November 11, 2020
FDA advises health care professionals and patients about insulin pen packaging and dispensing. October 28, 2020
FDA Safety Communication: flexible bronchoscopes and updated recommendations for reprocessing. February 24, 2022 - February 24, 2022
Cardinal Health recalls Argyle UVC insertion tray due to missing instructions for use for the Safety Scalpel N11. September 1, 2021
Reporting of death in US Food and Drug Administration medical device adverse event reports in categories other than death. August 11, 2021
FDA alerts health care professionals to the temporary absence of warning statement on the vial caps of two neuromuscular blocking agents. July 15, 2020
Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up. October 19, 2022
Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff. October 3, 2022
Implantable infusion pumps in the magnetic resonance (MR) environment: FDA safety communication—important safety precautions. January 25, 2017
FDA Drug Safety Communication: FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor). August 12, 2015
FDA Safety Communication: update--robotically-assisted surgical devices in mastectomy. August 20, 2021
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 17, 2019
Potentially fatal errors with GDH-PQQ [glucose dehydrogenase pyrroloquinoline quinone] glucose monitoring technology. October 21, 2009
Hydrocodone bitartrate and acetaminophen tablets, phenobarbital tablets by Qualitest: recall—incorrect package labeling. February 16, 2011
Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL): medication use error—reports of accidental overdose. January 19, 2011
FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death. October 9, 2013
Important change to heparin container labels to clearly state the total drug strength. December 19, 2012
Kadcyla (ado-trastuzumab emtansine): drug safety communication—potential medication errors resulting from name confusion. May 15, 2013
Hospira Carpuject pre-filled cartridges—drug alert: products may contain more than the intended fill volume. May 30, 2012
Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays. November 7, 2012
Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death. February 20, 2013
FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management. November 28, 2018
FDA Safety Communication: recommendations to reduce surgical fires and related patient injury. June 20, 2018
FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older. February 7, 2018
FDA Funding Available for Research Aimed at Reducing Preventable Harm from Medication November 6, 2019
Heparin sodium injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL medication errors. February 21, 2007
Roxane Laboratories initiates a nationwide voluntary recall of a single manufacturing lot of Azathioprine tablets in the U.S. and Puerto Rico. July 26, 2006
Handling injectable medications in anaesthesia: Guidelines from the Association of Anaesthetists. August 23, 2023
Medication guides: patient medication information. A proposed rule by the Food and Drug Administration. June 28, 2023
Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up. October 19, 2022
Agency Information Collection Activities: Proposed Collection; Comment Request, "Hospital Survey on Patient Safety Culture Comparative Database.'' June 22, 2022
Potential for medication overdose with ENFit low dose tip syringe: FDA Safety Communication. October 20, 2021
Agency information collection activities: National Healthcare Safety Network (NHSN); comment request. October 13, 2021
Agency information collection activities: Nursing Home Survey on Patient Safety Culture Database; comment request. October 6, 2021
Cardinal Health recalls Argyle UVC insertion tray due to missing instructions for use for the Safety Scalpel N11. September 1, 2021
FDA Safety Communication: update--robotically-assisted surgical devices in mastectomy. August 20, 2021
FDA Safety Communication: flexible bronchoscopes and updated recommendations for reprocessing. February 24, 2022 - February 24, 2022
Meitheal Pharmaceuticals, Inc. issues voluntary nationwide recall of Cisatracurium Besylate Injection, USP 10mg per 5mL due to mislabeling. February 10, 2021
FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only. February 3, 2021
Potential for false positive results with antigen tests for rapid detection of SARS-CoV-2--letter to clinical laboratory staff and health care providers. November 11, 2020
FDA advises health care professionals and patients about insulin pen packaging and dispensing. October 28, 2020
FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder. August 5, 2020
FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration. April 8, 2020
Catastrophic drug errors involving tranexamic acid administered during spinal anaesthesia. June 5, 2019
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 17, 2019