FDA MedWatch – Cataplex ACP, Cataplex C, and Pancreatrophin PMG Dietary Supplements
Cataplex ACP, Cataplex C, and Pancreatrophin PMG Dietary Supplements: Recall – Potential for Contamination With Salmonella
AUDIENCE: Consumer, Healthcare Professional
ISSUE: Standard Process and FDA notified consumers and healthcare professionals of a recall of three dietary supplements due to potential Salmonella contamination:
Cataplex ACP (Product number 0700 and 0750) Lot 114
Cataplex C (Product number 1650 1655) Lot 114
Pancreatrophin PMG (Product number 6650) Lot 114
This recall resulted during a routine FDA record inspection which revealed that one of the ingredients used in these products potentially contained the bacteria. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
BACKGROUND: The products, all tablets, were distributed in 60 cc and 200 cc amber glass bottles with Best Used By dates (BUB) of 5/13 indicated on both the bottles and the boxes. No other products or lot numbers are affected. The products were sold to consumers through health care professionals.
RECOMMENDATION: Consumers who have purchased any of these three products with specific lot codes of L114 are urged to return it to the place of purchase for a full refund. Consumers and health care professionals with questions can contact Standard Process Inc. at 866-397-3237.
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
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 links to the Press Release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm310334.htm
FDA MedWatch – Vecuronium Bromide for Injection Preservative Free (Bedford Laboratories)
Vecuronium Bromide For Injection Preservative Free (Bedford Laboratories): Recall – Particulate Matter
AUDIENCE: Risk Manager, Pharmacy, Surgery, Anesthesia
ISSUE: Bedford Laboratories issued recall of Vecuronium Bromide For Injection, 20 mg vial – NDC #55390‐039‐10, Lot 2067134, Exp. Date 5/31/2013 – due to the discovery of particulate matter in a small number of vials. This recall is for lot 2067134 only. Particulate matter has been recognized as a potential health hazard. Adverse reactions may include vein irritation and phlebitis, clinically occult pulmonary granulomas detected at routine autopsy examination, local tissue infarction, severe pulmonary dysfunction, occlusion of capillaries and arteries, anaphylactic shock and death.
To date, there have been no reports of any adverse events for the lot being recalled.
BACKGROUND: Vecuronium Bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
RECOMMENDATION: Healthcare practitioners who had received the lot are instructed not to use the product and immediately quarantine it for return. Read the Firm Press Release for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
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 Press Release, at:
FDA MedWatch – Ondansetron (Zofran) IV
Ondansetron (Zofran) IV: Drug Safety Communication – QT prolongation
AUDIENCE: Oncology, Surgery, Gastroenterology
ISSUE: The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.
GlaxoSmithKline (GSK) has announced changes to the Zofran drug label to remove the 32 mg single intravenous dose. The updated label will state that ondansetron can continue to be used in adults and children with chemotherapy-induced nausea and vomiting at the lower intravenous dose recommended in the drug label, a dose of 0.15 mg/kg administered every 4 hours for three doses; however, no single intravenous dose should exceed 16 mg. Information from the new clinical study will be included in the updated drug label.
BACKGROUND: Zofran (ondansetron) is in a class of medications called 5-HT3 receptor antagonists. It is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. FDA will evaluate the final study results when available, and will work with GSK to explore an alternative single dose regimen that is both safe and effective for the prevention of chemotherapy-induced nausea and vomiting in adults.
RECOMMENDATION: The new information on QT prolongation does not change any of the recommended oral dosing regimens for ondansetron. It also does not change the recommended lower dose intravenous dosing of ondansetron to prevent post-operative nausea and vomiting.
The use of a single 32 mg intravenous dose of ondansetron should be avoided. New information indicates that QT prolongation occurs in a dose-dependent manner, and specifically at a single intravenous dose of 32 mg.
Patients who may be at particular risk for QT prolongation with ondansentron are those with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or patients taking concomitant medications that prolong the QT interval
Electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia) should be corrected prior to the infusion of ondansetron.
The lower dose intravenous regimen of 0.15 mg/kg every 4 hours for three doses may be used in adults with chemotherapy-induced nausea and vomiting. However, no single intravenous dose of ondansetron should exceed 16 mg due to the risk of QT prolongation.
The new information does not change any of the recommended oral dosing regimens for ondansetron, including the single oral dose of 24 mg for chemotherapy induced nausea and vomiting.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
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 Drug Safety Communication, at:
FDA MedWatch – ev3 Onyx Liquid Embolic System
ev3 Onyx Liquid Embolic System: Safety Communication – Risk of Catheter Entrapment
AUDIENCE: Neurology, Surgery
ISSUE: FDA notified physicians and patients about the risk of catheter entrapment associated with the use of Onyx. Catheter entrapment happens when the catheter becomes stuck in the implanted Onyx material. The most serious complications include hemorrhage and death. Other complications include migration of the Onyx plug or catheter fragment to other parts of the body. Patients with catheter entrapment may need to take antithrombotic drugs to prevent blood clots around the catheter, and may need to undergo one or more imaging procedures to locate a piece of the catheter and Onyx plug, increasing their exposure to radiation.
The FDA approved changes to the physician and patient labeling that reflect the risks related to catheter entrapment. The labeling also includes recommendations to help minimize the risk of entrapment. Physicians should expect to see this labeling in new orders of Onyx.
BACKGROUND: The Onyx Liquid Embolic System (“Onyx”), manufactured by ev3, is a liquid material used to block blood flow in abnormally formed blood vessels in the brain, also know as brain arteriovenous malformations or brain AVMs, before their surgical removal. A catheter is used to deliver the Onyx liquid to blood vessels in the brain.
RECOMMENDATIONS: Catheter entrapment is unlikely to affect the physician’s ability to surgically remove the patient’s AVM. However, neither Onyx nor the catheter is intended to be long-term implants, and patients may need additional medical interventions to have the catheter removed if it becomes entrapped.
Neuro interventionalists should select patients carefully, after reviewing the most recent device labeling and instructions.
Onyx is only approved for use in patients who will undergo surgical removal of the treated brain AVM.
Onyx has not been tested or approved as a long-term implant.
Healthcare professionals should be prepared to treat serious complications associated with the use of Onyx and ensure that your facility is staffed and equipped to address these complications should they arise.
Read the FDA Safety Communication for additional information.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with the Onyx Liquid Embolic System, including a difficult to remove or entrapped (retained) catheter while using Onyx, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
Please include the following information in your reports, if available:
Adverse event details (date adverse event occurred; complications that occurred, e.g. retained or plugged catheter, migration of Onyx plug, hemorrhage of the brain AVM; and the medical intervention required)
Type of Onyx used (e.g. Onyx 18 or Onyx 34)
Expiration dates of Onyx, delivery catheter and all accessories used
Model and size of catheter used with Onyx
Location in the anatomy where Onyx was used
Amount (distance) of reflux
Whether vessel was in vasospasm
Whether surgical resection is planned
Location in the pedicle being embolized where the catheter got stuck. For example, proximity to the origin of the pedicle vessel and proximity to the Onyx plug.
Whether additional medical therapies (e.g. antithrombotics) were needed
To report adverse events or side effects related to the use of this product:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
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 safety communication, at:
May 2012 Drug Safety Labeling Changes
Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.
Lotensin (benazepril) *Fetal Toxicity
Divigel (estradiol gel)
Focalin (dexmethylphenidate hydrochloride)
Focalin(dexmethylphenidate hydrochloride)
Gilenya (Fingolimod)
2% Chlorhexidine Gluconate (CHG) Cloth
Aciphex (rabeprazole sodium) Delayed-Release Tablets
Actoplus Met (pioglitazone hydrochloride plus metformin hydrochloride) Tablets
Aredia (pamidronate disodium) for Injection
Avagard Surgical and Healthcare Personnel Hand Antiseptic (chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w) Lotion
Biaxin Filmtabs (clarithromycin tablets, USP)
Biaxin Granules (clarithromycin for oral suspension, USP)
Biaxin XL Filmtabs (clarithromycin extended release tablets)
Catapres (clonidine hydrochloride) Tablets
Catapres-TTS (clonidine) Transdermal Therapeutic System
Chlorascrub Swabsticks
Dexilant (dexlansoprazole) delayed-release capsules
Folotyn (pralatrexate injection)
Hibiclens (4% w/v chlorhexidine gluconate) solution
Hibistat (0.5% chlorhexidine gluconate solution and 70% isopropyl alcohol w/w)
Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets
Prevacid (lansoprazole) Delayed-Release Capsules Prevacid (lansoprazole) Delayed-Release Orally Disintegrating Tablets
Protonix (pantoprazole sodium) For Injection
Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension Protonix (pantoprazole sodium) Delayed-Release Tablets
Scrub-Stat 2% and Scrub-Stat 4% (chlorhexidine gluconate 2% and 4%) Solutions
Ultravist (brand of iopromide) Injection
Ultravist (brand of iopromide) Injection Pharmacy Bulk Pack
Zarontin (ethosuximide) Capsules
Cubicin (daptomycin for injection) Intravenous
Effexor (venlafaxine HCl) Tablets Effexor XR (venlafaxine HCl) Extended-Release Capsules
Ella (ulipristal acetate)
Levemir (insulin detemir [rDNA origin]), Injection
Prolia (denosumab)
Stelara (ustekinumab) Injection
Tradjenta (linagliptin) Tablets
Venlafaxine HCl Extended-release Tablets
Amevive (alefacept)
Avastin (bevacizumab)
DuoNeb (albuterol sulfate and ipratropium bromide) Inhalation Solution
Humira (adalimumab)
Neupogen (filgrastim)
Zestril (lisinopril) tablets
Zestoretic (lisinopril/hydrochlorothiazide) tablets
Dysport (abobotulinumtoxinA)
Revlimid (lenalidomide) Capsules
FDA MedWatch – Digestive 3 in 1 Health Liquid Dietary Supplement: Recall
ISSUE: Botanical Laboratories Inc. and FDA notified consumers and healthcare professionals of a recall of Wellesse Digestive 3 in 1 Health liquid dietary supplement. A supplier of one of the ingredients indicated the ingredient has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience: fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
BACKGROUND: Product lots affected by this recall include: 16 oz. size with “LOT 34441C (followed by a four digit time code) A EXP 03/2014” jet coded on the bottom of the bottle. 33.8 oz. size has “LOT 34552C (followed by a four digit time code) A EXP 03/2014” jet coded on the bottom of the bottle.
Both 33.8 oz. and 16 oz “Digestive 3 in 1 Health” were distributed nationwide through retail stores, and online retailers. The product was distributed after 05/01/2012.
RECOMMENDATION: Consumers who have purchased Wellesse “Digestive 3 in 1 Health” with one of the above referenced lot numbers are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-232-4005.
Consumers 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.htm
• 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
CLICK HERE to read the MedWatch safety alert, including links to the Press Release and photos.
FDA MedWatch – Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall
ISSUE: Sandoz notified the public that it issued a voluntary recall of 10 lots of its generic oral contraceptive Introvale in the US, following a recent report of a packaging flaw. A consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled “Week 13”). Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week. While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.
The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the US between January 2011 and May 2012.
BACKGROUND: Introvale is an extended-cycle oral contraceptive. Sandoz is not aware of any reports of related adverse events.
RECOMMENDATION: If a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception and contact their healthcare professional.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or quality problems 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.htm
• 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
CLICK HERE to read the MedWatch safety alert, inlcuding a link to the firm press release.
FDA MedWatch – Zithromax (azithromycin): FDA Statement on risk of cardiovascular death
ISSUE: FDA notified healthcare professionals that it is aware of the study published in the New England Journal of Medicine May 17, 2012 reporting a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. FDA is reviewing the results from this study and will communicate any new information on azithromycin and this study or the potential risk of QT interval prolongation after the agency has completed its review.
BACKGROUND:Azithromycin belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects; specifically, prolongation of the QT interval. In 2011, FDA reviewed macrolide drug labeling information related to QT interval prolongation and TdP. The WARNINGS AND PRECAUTIONS section of the Zmax drug label (azithromycin extended release for oral suspension) was revised in March 2012 to include new information regarding risk for QT interval prolongation, which appears to be low. The drug labels for clarithromycin and erythromycin also contain information about QT interval prolongation in the WARNINGS section. FDA is in the process of updating risk information in the drug labels for additional macrolide antibacterial drugs.
RECOMMENDATION: Patients taking azithromycin should not stop taking their medicine without talking to their healthcare professional. Healthcare professionals should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering macrolides.
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.htm
• 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
CLICK HERE to read the MedWatch safety alert, including a link to the Drug Safety Communication.
FDA MedWatch – Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall
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:
• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• 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
CLICK HERE to read the MeDWatch safety alert, including a link to the updated Drug Safety Communication.
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