Natural Creations Issues Allergy Alert steady Undeclared Milk Ingredient in Dietary Supplement New Zealand Colostrum
05/15/2015 03:24 PM EDT
Natural Creations of Woodbine, IA is recalling a little quantity of Natural Creations New Zealand Colostrum because the label does not inform consumers that the product is milk-based. People who be obliged an allergy or severe sensitivity to milk protein move on the risk of serious allergic reaction if they consume this product.
OC Raw Dog Recalls Turkey & Produce Raw Frozen Canine Formulation Because of Possible Salmonella Health Risk
05/15/2015 08:48 PM EDT
OC Raw Dog of Rancho Santa Margarita, CA is voluntarily recalling 2055 lbs. of Turkey & Produce Raw Frozen Canine Formulation, since it has the potential to be contaminated with Salmonella. An organism what one. can cause serious and sometimes baleful infections in young children, frail or somewhat advanced in life people, and others with weakened immune systems.
Aurora Products, Inc. Announces Voluntarily Recall of Aurora Natural Brand and Certain Private Label Branded Raw Macadamia Nuts Due to Possible Health Risk
05/15/2015 10:09 PM EDT
Aurora Products, Inc. is conducting a intentional recall of RAW MACADAMIA NUTS packaged beneath the Aurora brand label and uncertain Store brand labels. Products are substance recalled because they have the in posse to contain Salmonella which can reason serious and sometimes fatal infections in young children, frangible or elderly people, and others through weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
OC Raw Dog Recalls Turkey & Produce Raw Frozen Canine Formulation Because of Possible Salmonella Health Risk – http://www.fda.gov/Safety/Recalls/ucm447095.htm
CVM Update – FDA Releases Draft Guidance up~ the body Animal Drug Compounding from Bulk Drug Substances – http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm446846.htm
CVM Update – FDA Releases Proposed Rule to Collect Antimicrobial Sales and Distribution Information ~ means of Animal Species – http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm446803.htm
CVM Updates – http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/default.htm
CVM FR Notices – http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ucm216453.htm
Visit our home boy-servant at http://www.fda.gov/AnimalVeterinary/default.htm
FDA Reaches Out to Minorities During Hepatitis Awareness Month
By: Jovonni R. Spinner, M.P.H., C.H.E.S
Did you know that millions of Americans (mostly baby boomers) are living with chronic Hepatitis and up to 2/3 may not on a level know they are infected? Annually, in May, the men health community commemorates “Hepatitis Awareness Month” to attend attention to this disease, its symptoms, testing, and handling options. This year, we are laboring with the Centers for Disease Control and Prevention (CDC) to leadership outreach for minority groups most affected by Hepatitis: Asian/Pacific Islanders (API) and African-Americans (AA). … Continue version
Drug Information Update- From our prospect: The U.S. drug supply restrain and patient safety
Ilisa Bernstein, Pharm.D., J.D., Deputy Director of FDA’s Center as being Drug Evaluation and Research’s Office of Compliance, shares her thoughts up~ the body the important role drug supply fasten with a ~ integrity plays in patient safety and station care.
For more information, please inspect: Drug Supply Chain
Drug Information Update- FDA Drug Safety Communication: FDA cautions over dose confusion and medication errors ~ the sake of antibacterial drug Zerbaxa (ceftolozane and tazobactam)
The U.S. Food and Drug Administration (FDA) is augury health care professionals about the expose to danger for dosing errors with the antibacterial drug Zerbaxa (ceftolozane and tazobactam) due to bewilderment about the drug strength displayed up~ the vial and carton labeling. Zerbaxa’s vial label was initially approved with a spirit that reflects each individual active element (e.g. 1 g/0.5 g); but, the product is dosed based without ceasing the sum of these ingredients (e.g. 1.5 g). To prevent future medication errors, the strength up~ the drug labeling has been revised to mirror the sum of the two sprightly ingredients. Thus, one vial of Zerbaxa will now list the strength as 1.5 grams synonymous to ceftolozane 1 gram and tazobactam 0.5 gram (See Label Photos).
Zerbaxa is used to bargain complicated infections in the urinary part, or in combination with the antibacterial deaden with narcotics metronidazole to treat complicated infections in the belly. Antibacterial drugs work by killing or stopping the produce of bacteria that can cause ailing.
We evaluated seven reported cases of medication error that occurred during preparation of the disagreeable lot in the pharmacy due to overthrow with the display of the firmness of individual ingredients on Zerbaxa’s vial label and carton labeling. Listing the individual medicine strengths led to confusion because it was variant from labeling for other beta-lactam/beta-lactamase antibacterial drugs that signify strength as the sum of the couple active ingredients. In some cases, this led to distribution of 50% more drug than was prescribed. No hostile events were reported among these seven cases.
To learn added, please visit: Zerbaxa.
If you obtain comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am – 4:30 pm ET Monday – Friday. You can also email us at firstname.lastname@example.org.
For additional drug information, please visit the DDI Web page.
For up-to-date drug intelligence, follow the FDA’s Division of Drug Information without interrupti~ Twitter: FDA_Drug_Info.
Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication – FDA Cautions About Dose Confusion and Medication Errors
AUDIENCE: Nursing, Pharmacy, Risk Manager
ISSUE: The U.S. Food and Drug Administration (FDA) is augury health care professionals about the endanger for dosing errors with the antibacterial medicine Zerbaxa (ceftolozane and tazobactam) due to tumult about the drug strength displayed put ~ the vial and carton labeling. (See the Drug Safety Communication as antidote to Label Photos).
FDA evaluated seven reported cases of medication mistake that occurred during preparation of the drench in the pharmacy due to mortification with the display of the boldness of individual ingredients on Zerbaxa’s small bottle labels and carton labeling. Listing the individual drug strengths led to confusion because it was variant from labeling for other drugs in the beta-lactam/beta-lactamase class that express strength as the question of the two active ingredients. In more cases, this led to administration of 50% added drug than was prescribed. No adverse events were reported among these seven cases.
BACKGROUND: Zerbaxa is used to bargain complicated infections in the urinary territory, or in combination with the antibacterial deaden with narcotics metronidazole to treat complicated infections in the belly. Antibacterial drugs work by killing or stopping the improvement of bacteria that can cause distemper.
RECOMMENDATION: FDA urges health care professionals and patients to communicate side effects and medication errors involving Zerbaxa to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the record Online: ww.fda.gov/MedWatch/promulgate.htm
Download form or call 1-800-332-1088 to beg for a reporting form, then complete and return to the address on the pre-addressed figure, or submit by fax to 1-800-FDA-0178
Read the MedWatch preservation alert, including links to the Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm447629.htm
Drug Shortages Update
May 18, 2015
FDA Drug Shortages
Cefazolin Injection (Updated – Currently in Shortage)
Nalbuphine Hydrochloride (Nubain) Injection (Updated- Resolved)
Piperacillin and Tazobactam (Zosyn) Injection (Updated – Currently in Shortage)
Sodium Phosphate Injection (Updated – Resolved)
Trace Elements (Updated – Currently in Shortage)
Trypan Blue (Membraneblue) (Updated – Resolved)
May 21, 2015
FDA Drug Shortages
Dimercaprol (Bal-in-Oil) Injection (Updated – Resolved)
Fluorescein Sodium Injection (Updated – Resolved)
Download the Drug Shortages Mobile Application
Recent Device Approvals: cobas KRAS Mutation Test
The FDA has recently approved the cobas KRAS Mutation Test, some automated molecular assay designed to descry the presence of mutations in the KRAS gene in colorectal cancer (CRC) tumefaction tissue. In normal tissue, the KRAS protein helps stimulus or stop cell growth; mutations in the KRAS protein disrupt this regulated measure.
Erbitux (cetuximab) and Vectibix (panitumumab) are cancer medicines used to treat patients with CRC that starts in the colon or rectum and spreads to other regions of the body. Mutations in the KRAS protein likely block the beneficial effect of Erbitux or Vectibix. If the cobas KRAS Mutation Test shows that a change is present in the CRC tumor tissue, then treatment with Erbitux or Vectibix is not recommended in spite of the patient.
If the cobas KRAS Mutation Test does not find a mutation, then the patient may have existence eligible for treatment with Erbitux or Vectibix.
For greater degree of information, please see: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm447256.htm
Recent Device Approvals: MAMMOMAT Inspiration with Tomosynthesis
The FDA has freshly approved the MAMMOMAT Inspiration with Tomosynthesis to have ~ing marketed. MAMMOMAT Inspiration with Tomosynthesis Option is a mammography trick that produces 2D digital images viewed like well as multiple cross-sectional images of the chest for the screening and diagnosis of chest cancer. For more information, please care for: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm447240.htm
FDA Teams With National Forum to Reduce Deaths from Heart Disease: Program is earliest of its kind
By: Heidi C. Marchand, Pharm.D.
In the U.S., barely about 1 in every 4 prescriptions is taken at the same time that directed by a health care provider — a enigma that costs our nation more than 125,000 lives a year. Millions of Americans … Continue prelection
What’s New at CBER Update
May 15, 2015 Approval Letter – Fluvirin (PDF – 28KB)
May 9, 2015 Approval Letter – Kogenate FS (PDF – 37KB)
Approval History, Letters, Reviews, and Related Documents – RAPLIXA
Summary Basis since Regulatory Action – RAPLIXA (PDF – 334KB)
Platelet PGD Test System: BK140201
Summary Basis in spite of Regulatory Action – IXINITY (PDF – 450KB)
U.S. Food & Drug Administration (FDA) NCTR Research Highlights Update
Progress in c~tinuance FDA Studies Reviewed
A&S Food Trading Inc. Issues each Alert on Undeclared Sulfites in Hua Zhi Ying Brand Gourd Candy
05/19/2015 06:50 PM EDT
A&S FOOD TRADING INC at 4425B 1ST AVE, BROOKLYN, NEW YORK 11232 is recalling HUA ZHI YING BRAND GOURD CANDY for the reason that it contains undeclared sulfites. People who esteem severe sensitivity to sulfites run the danger of serious or life-threatening allergic reactions grant that they consume this product.
Blue Bell and the Very Real Impact of the Food Safety Modernization Act
By: Michael R. Taylor
Could the mortal outbreak of illnesses tied to contaminated concreted sugar cream have been prevented? It’s an important question, one that is attached the minds of many in the stimulate of the multi-state outbreak of Listeria monocytogenes … Continue lecture
Enforcement Report for May 20, 2015
05/20/2015 01:00 AM EDT
U.S. Food & Drug Administration (FDA) FDA/CFSAN Cosmetics News Update
Recalls & Alerts:
Sensible Organics, Inc.: Nourish Organic Face Cream and Nourish Organic Face Lotion: May Contain Mold
Tattoofun, Inc.: Lulu DK Joico Turn Heads, Metallic Temporary Tattoos: Undeclared Ingredients
What FDA Learned About Dark Chocolate and Milk Allergies
05/21/2015 1:15 PM EDT
FDA is releasing greater quantity information about its study finding that some dark chocolate products contain varying amounts of milk. And you be able to’t always tell that’s the put in a box simply by reading the food label.
Read the Consumer Update to learn other thing.
Medication Guides Updated
The FDA Medication Guides gain been updated to include:
AFREZZA® (insulin human) inhaling powder, MannKind Corporation
DULERA® 100 mcg/5 mcg (mometasone furoate 100 mcg and formoterol fumarate dihydrate 5 mcg) Inhalation Aerosol, DULERA® 200 mcg/5 mcg (mometasone furoate 200 mcg and formoterol fumarate dihydrate 5 mcg) Inhalation Aerosol, Merck & Co., Inc.
JUXTAPID® (lomitapide) capsules, Aegerion Pharmaceuticals, Inc.
METADATE CD® (methylphenidate HCl, USP) Extended-Release Capsules CII, UCB, Inc.
NUVIGIL C-IV (armodafinil) Tablets, Teva Pharmaceuticals USA, Inc.
QUILLIVANT XR® (methylphenidate hydrochloride) on this account that extended-release oral suspension CII, Pfizer, Inc.
Reclast® (zoledronic sour) Injection, Novartis Pharmaceuticals Corporation
Ritalin (methylphenidate hydrochloride, USP)
Ritalin SR (methylphenidate hydrochloride, USP) sustained absolution tablet
ZONTIVITY® (vorapaxar) Tablets, Merck Sharp and Dohme
To have capacity for information about a broad range of FDA topics, ponder subscribing to the FDA Patient Network News or Updates because Health Care Professionals or specific topics.
Dell, MD, one orthopedic surgeon at Kaiser Permanente Medical Center in Cypress, Calif.