Health Advisories

 

 

FRIDAY, JULY 7, 2017

Patients Receiving Eculizumab (Soliris®) at High Risk for Invasive Meningococcal Disease Despite Vaccination. The CDC has issued a health advisory regarding the risk for invasive meningococcal disease in patients receiving eculizumab (Soliris). Investigations of invasive meningococcal disease should include inquiring about a history of receipt of eculizumab. Healthcare providers should maintain a high index of suspicion for meningococcal disease in patients taking eculizumab who present with any symptoms consistent with either meningitis or meningococcemia, even if the patient’s symptoms initially appear mild, and irrespective of the patient’s meningococcal vaccine or antimicrobial prophylaxis status.

http://www.ncbop.org/PDF/MeningococcalDiseaseDespiteVaccination07072017.pdf

 


FRIDAY, JUNE 9, 2017

LUPIN PHARMACEUTICALS RECALLS LOT L600518 MIBELAS 24 FE TABLETS.  Pharmacists should be aware that Lupin Pharmaceuticals Inc. announced that it has voluntarily recalled lot L600518, Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets at the consumer level. A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets.

As a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at  risk for contraceptive failure and unintended pregnancy. The reversing the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the tablets out of order.
More information may be found here:  https://www.fda.gov/safety/recalls/ucm560904.htm

 


 

MONDAY, APRIL 24, 2017

NORTH CAROLINA DIVISION OF PUBLIC HEALTH ISSUES CLINICIAN GUIDANCE ON MUMPS TREATMENT.  In recent weeks, the North Carolina Division of Public Health (NC DPH) has received reports of mumps cases from local health departments.  The guidance (found here) from NC DPH is intended to aid all health care providers with regard to reporting, testing, prevention, and control measures for mumps: http://www.ncbop.org/PDF/MumpsClinicianGuidanceNCDHHS042117.pdf.

 


 

MONDAY, MARCH 7, 2016

Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg per 100ml Due to the Discovery of an Out of Specification Impurity Result Detected During Routine Quality Testing of Stability Samples at the 18-Month Interval.

http://www.fda.gov/Safety/Recalls/ucm489303.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery



THURSDAY, DECEMBER 10, 2015

Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Statement - FDA Warns of Potential Contamination

AUDIENCE
: Health Professional, Anesthesiology, Pain Management, Neurology, Pharmacy

ISSUE
: FDA is alerting drug compounders that certain lots of baclofen active pharmaceutical ingredient (API) manufactured by Taizhou Xinyou Pharmaceutical & Chemical Co., Limited (Taizhou) Taizhou City, Zhejiang Province, China, may be at risk for contamination with particulates and should not be used to compound sterile injectable drugs.

BACKGROUND
: Taizhou manufactures APIs for repackagers and distributors, some of which sell these products to compounding facilities in the United States. FDA contacted Taizhou through its US agent, and the company confirmed that, due to the level of controls in the manufacturing process, the baclofen API it manufactures is not suitable for use in injectable drugs. Based on available information, the affected API may potentially pose serious safety risks for U.S. patients who use or receive injectable drug products compounded with the affected baclofen, especially when administered directly into the spinal column. For example, use of baclofen API contaminated with particulate matter can result in serious injury if injected directly into the spinal column and may also clog pumps used to administer the medication. There is also a potential risk that the baclofen API may be contaminated by endotoxin or microorganisms. FDA is continuing to investigate this incident.

RECOMMENDATION: FDA recommends that no baclofen API from Taizhou be used to manufacture or compound any injectable drugs. 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.fda.gov/MedWatch/report
• 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.
Read the MedWatch Safety Alert, including a link to the FDA Statement, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm476514.htm

 


 

THURSDAY, NOVEMBER 12, 2015

Sanofi US Recalls All Lots of Auvi-Q Epinephrine Injection, USP

Sanofi US of Bridgewater, NJ, has announced a voluntary recall of all lots of Auvi-Q® (epinephrine injection, USP) 0.15 mg and 0.3 mg strengths to the hospital, retail, and consumer level. This recall affects lot numbers 2081278 through 3037230, which expire October 2015 through December 2016. The recalled Auvi-Q products are packaged with two active devices and one trainer device in a corrugated box, and were distributed throughout the United States via wholesalers, pharmacies, and hospitals. Auvi-Q is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. As noted in a Food and Drug Administration (FDA) safety alert, the products may potentially have inaccurate dosage delivery, which may include failure to deliver the drug. If a patient experiencing anaphylaxis did not receive the intended dose, there could be significant health consequences, including death, because anaphylaxis is a potentially life-threatening condition.

As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. None of these device malfunction reports have been confirmed. To date, no fatal outcomes have been reported among these cases. Sanofi US is notifying its distributors and customers, who include doctors, pharmacies, wholesalers, and other customers in the supply chain, and is making arrangements for return and reimbursement of all recalled products. Customers are advised to contact the company using information provided in the FDA Safety Alert and by visiting www.Auvi-Q.com.

Patients should immediately contact their health care provider for a prescription for an alternate epinephrine auto-injector. In the event of anaphylaxis, patients should only use their Auvi-Q device if another epinephrine auto-injector is not available and then call 911 or local medical emergency services. Patients should contact their physician or health care provider if they have experienced any problems that may be related to using this drug product. Adverse reactions or quality problems may be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

 


 

WEDNESDAY, SEPTEMBER 16, 2015

US Compounding Pharmacy Announces Voluntary Recall of All Lots of Sterile Products Aseptically Compounded and Packaged that Remain Within Expiry. Read the press release here.

 


 

FRIDAY, SEPTEMBER 11, 2015 - UPDATED ALERT RE: MEDISTAT RX RECALL

FDA Announces Medistat RX’s Nationwide Voluntary Recall of Sterile Drug Products

FOR IMMEDIATE RELEASE – The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of all non-expired drug products produced for sterile use and distributed nationwide by Medistat RX, LLC, in Foley, Alabama, due to possible contamination. The recalled products were distributed between November 1, 2014, and September 3, 2015.

Contaminated drugs put patients at risk of serious infection. Health care professionals should immediately check their medical supplies, quarantine any drug products marketed as sterile from Medistat, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

During an ongoing inspection, FDA investigators and Alabama state inspectors observed significant deficiencies that raise concerns about Medistat’s ability to assure the sterility of drug products that it produced. Medistat voluntarily ceased sterile compounding operations on September 1, 2015.

MORE INFORMATION HERE.

 


 

WEDNESDAY, SEPTEMBER 9, 2015

Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning
Alert now includes 1 mL, 10 mL, 20 mL, and 30 mL BD syringes, and BD oral syringes


AUDIENCE: Pharmacy, Nursing, Risk Manager, Compounding

ISSUE: FDA is expanding its alert regarding compounded or repackaged drugs stored in Becton-Dickinson (BD) general use syringes to include certain additional syringe sizes including 1mL, 10mL, 20mL and 30mL BD syringes, and BD oral syringes. See the FDA Alert for links to the BD webpage to determine which specific lots are affected. FDA continues to investigate this issue and will provide more information when it is available.

BACKGROUND: FDA’s original alert applied to compounded or repackaged drugs that have been stored in 3 mL and 5mL BD syringes. This expansion of the alert to include additional sizes of syringes is based on BD reports that an interaction with the rubber stopper in certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately. BD reports that the following drugs in particular can be affected by the stoppers, but FDA does not know whether other drugs can be affected: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanyl.

RECOMMENDATION: Hospital pharmacies and staff should:

• Contact any outsourcers to determine if affected lots of BD syringes were used for compounded or repackaged products
• Not administer compounded or repackaged drugs that have been stored in any of these syringes unless there is no suitable alternative available.
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.fda.gov/MedWatch/report
• 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.

Read the MedWatch Safety Alert, including a link to the FDA Alert at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm461597.htm



 

THURSDAY, MARCH 12, 2015

ATTENTION HOSPITAL PHARMACISTS AND PHYSICIANS: Sandoz Pharmaceuticals is recalling multiple lots of fomepizole injection apparently due to FDA concerns at one of the manufacturing facilities. For affected lots and Carolinas Poison Center recommendations for action, please see  http://www.ncpoisoncenter.org/body.cfm?id=36&action=detail&ref=93.

 


FRIDAY, OCTOBER 24, 2014

NORTH CAROLINA DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES ADDITIONAL EBOLA GUIDANCE FOR NON-HOSPITAL HEALTH CARE SETTINGS. Pharmacists are also reminded that they may have patients with questions and concerns about Ebola virus disease. Some patients (and health care providers) may have received inaccurate information about Ebola virus disease. North Carolina DHHS has created a website with information for the public and for health care providers: http://www.ncdhhs.gov/ebola/ (See also the October 17, 2014 update below.) On Thursday evening, DHHS updated its Ebola virus disease information website with additional guidance documents, including specific guidance for health care practitioners in non-hospital settings.   The new guidance documents may be found here: http://www.ncbop.org/PDF/EbolaGuidanceNCforNonHospitalSettings10_23_%2014.pdf

and here: http://www.ncbop.org/PDF/EbolaProviderGuidance10_23_2014.pdf – and on the DHHS website: http://www.ncdhhs.gov/ebola/.

 


 

WEDNESDAY, JULY 30, 2014

UNIQUE PHARMACEUTICALS HAS RECALLED ALL STERILE COMPOUNDED PREPARATIONS DUE TO LACK OF STERILITY ASSURANCE.  Unique Pharmaceuticals, Ltd, of Temple, TX, has announced a voluntary recall of all sterile drug preparations compounded by the outsourcing facility. The company initiated the recall due to FDA concerns regarding Unique’s compounding facilities and processes following recent inspections, according to a Unique Pharmaceuticals press release announcing the recall. Products recalled include all sterile compounded preparations that the company has supplied to its customers within expiry, distributed nationwide in syringes, vials, and bags. Nonsterile preparations are unaffected by the recall. Unique is notifying customers by phone, fax, mail, or personal visits and providing additional instructions for the recall. To date, there have been no reports of injury or illness associated with the use of these products. Adverse actions related to the use of this product may be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program. The FDA’s announcement may be found here:  http://www.fda.gov/Safety/Recalls/ucm405938.htm