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Patient Safety
Monday, October 5, 2015
Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: FDA Statem »
ISSUE: During FDA’s recent inspection of Park Compounding Pharmacy’s facility, FDA investigators observed insanitary cond...
Thursday, September 24, 2015
Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance »
ISSUE : US Compounding, Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by...
Wednesday, September 16, 2015
New FactFinder! Strategies to Minimize Risk in Lumbar Transforaminal Injections: Digital Subtraction »
A new FactFinder has been posted to the Patient Safety section. The intent of this FactFinder is to address strategies use...
Wednesday, September 16, 2015
Elite Biomedical Solutions, Alaris Medley Large Volume Pump (LVP) Frame Membrane, Frame Membrane May »
A recall has been issued for the Elite Biomedical Solutions, Alaris Medley Large Volume Pump (LVP) Frame Membrane.  E...
Wednesday, September 16, 2015
CareFusion Alaris Syringe Pump, Alarm Error May Cause Interruption of Therapy »
A recall has been issued for the CareFusion Alarms Syringe Pump . An error in the syringe pump triggers a visual and audi...
Wednesday, September 16, 2015
Medistat RX Sterile Drug Products: Recall - Possible Contamination »
On September 10th, FDA alerted health care professionals and patients of a voluntary recall of all non-expired drug produc...
Wednesday, September 9, 2015   (0 Comments - view/add)
Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning »
ISSUE : FDA is expanding its alert regarding compounded or repackaged drugs stored in Becton-Dickinson (BD) general use sy...
Wednesday, August 19, 2015
Prolotherapy with Phenol by Hartley Medical: Recall - Non-sterility Concerns »
ISSUE : Hartley Medical is recalling three lots of Prolotherapy with Phenol, Injectable to the hospital/user level due to...
Wednesday, August 19, 2015
Compounded Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning - Do Not Use »
ISSUE : FDA is alerting health care professionals not to administer to patients compounded or repackaged drugs that have b...
Monday, July 27, 2015
Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication »
ISSUE: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs)...
Monday, July 20, 2015
0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter »
On 7/20/15, Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the...
Tuesday, July 14, 2015
NSAIDs: Drug Safety Communication - FDA Strengthens Warning of Chance of Heart Attack or Stroke »
FDA is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the...
Friday, April 24, 2015
Hospira Issues A Voluntary Nationwide Recall Of One Lot Of Bupivacaine HCl Injection Due To Potentia »
Hospira, Inc. has announced today it is issuing a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injecti...
Thursday, April 2, 2015
Patient Safety Alert: FDA Alerts Health Care Professionals and Patients Not to Use Products from the »
The U.S. Food and Drug Administration is joining the North Carolina Board of Pharmacy (NC BOP) to urge health care profess...
Monday, December 29, 2014
Customed Inc., Surgical Convenience Packs - Compromised Sterility Due to Multiple Problems »
Recall Class: Class I Date Recall Initiated: October 8, 2014 Devices: Surgical Convenience Packs, Trays, a...
Friday, October 17, 2014
Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall »
ISSUE: Hospira announced it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per...
Friday, October 10, 2014
Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance »
ISSUE: Oregon Compounding Centers, Inc., also called Creative Compounds, is voluntarily recalling certain unexpired human...
Thursday, September 18, 2014
DEA Announces Moving Hydrocodone Combination Products from Schedule III to Schedule II »
The U. S. Drug Enforcement Administration (DEA) issued a final rule with a decision to move hydrocodone combination produc...
Sunday, July 20, 2014
Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assur »
Sterile Drug Products by Downing Labs (aka NuVision Pharmacy):  Drug Alert - Lack of Sterility Assurance  ...
Wednesday, July 16, 2014
FDA Outlines Expectations for Human Drug Compounders »
On July 1, the US Food and Drug Administration released multiple policy documents concerning compounded drug products for...
Wednesday, July 16, 2014
CDC Vital Signs on Opioid Prescribing Notes State Variability »
The July 1 Morbidity and Mortality Weekly Report (MMWR) from the CDC discusses prescribing rates of opioid pain relievers...
Wednesday, July 16, 2014
Joint Commission Issues Sentinel Event Alert (SEA): Preventing Infection from Misuse of Vials »
On June 16, the Joint Commission issued a SEA to raise awareness regarding the risk of infection due to misuse of single-d...
Friday, July 11, 2014
Sterile Drug Products by Unique Pharmaceuticals Ltd.: Recall - Lack of Sterility Assurance »
ISSUE: The U.S. Food and Drug Administration is alerting health care professionals, including hospital supply managers...
Wednesday, June 18, 2014
Hospira Announces Voluntary Nationwide Recall of One Lot of 0.5% Marcaine™ (Bupivacaine HCI Injectio »
Hospira Announces Voluntary Nationwide Recall of One Lot of 0.5% Marcaine™ (Bupivacaine HCI Injection, USP), 30 ML, Single...
Thursday, April 24, 2014
FDA Drug Safety Communication on Risk of Rare But Serious Neurologic Problems from Epidural Corticos »
FDA Drug Safety Communication on Risk of Rare But Serious Neurologic Problems from Epidural Corticosteroid Injections &...
Tuesday, April 22, 2014
Hospira Announces Voluntary Nationwide Recall of One Lot of 0.25% Marcaine™ (Bupivacaine HCI Injecti »
Hospira Announces Voluntary Nationwide Recall of One Lot of 0.25% Marcaine™ (Bupivacaine HCI Injection, USP), 10 ml, Singl...
Saturday, April 19, 2014
Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates »
ISSUE: Hospira, Inc. will initiate a voluntary recall of one lot of 1% Lidocaine HCI Injection, USP, 10mg/mL, 30 mL singl...
Friday, April 18, 2014
Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates »
ISSUE: Hospira notified the public of a nationwide recall of seven lots of Propofol Injectable Emulsion, 1%, 200 mg/20...
Thursday, March 13, 2014
Merit Medical Systems, Custom Procedural Trays/Kits Containing 1% Lidocaine HCl Injection, USP, 10mg »
Merit Medical Systems, Custom Procedural Trays/Kits Containing 1% Lidocaine HCl Injection, USP, 10mg/mL:  Class I Rec...
Wednesday, January 15, 2014
Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement – Recommen »
Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement – Recommendation to Discontinue...
Friday, December 27, 2013
Baxter 5 Percent Dextrose Injection, USP And 0.9 Percent Sodium Chloride Injection, USP Intravenous »
Baxter 5 Percent Dextrose Injection, USP And 0.9 Percent Sodium Chloride Injection, USP Intravenous (IV) Solutions: Recall...
Tuesday, December 24, 2013
2% Lidocaine HCL Injection by Hospira: Recall - Presence of Particulate Matter »
ISSUE: Hospira, Inc. announced it will initiate a voluntary nationwide recall to the user level for one lot of Lidocaine...
Thursday, December 19, 2013
Abrams Royal Pharmacy Recall – Lack of Sterility Assurance »
ISSUE : Abrams Royal Pharmacy is voluntarily recalling all unexpired lots of sterile products dispensed nationwide due to...
Wednesday, December 18, 2013
The Law of the Land: Drug Quality and Security Act »
WASHINGTON, DC -  On Wednesday, November 27 th , H.R. 3204, the Drug Quality and Security Act , was signed into l...
Wednesday, December 18, 2013
Hospira Inc., GemStar Infusion System Class I Recall – Pressure Sensor Calibration Drift »
ISSUE : The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Dist...

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