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FDA MedWatch Alerts

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RotaWire Elite Guidewire and wireClip Torquer Guidewire by Boston Scientific: Recall - Wires May Break and Separate from the Rotablator System

November 26, 2015

[Posted 11/27/2015] AUDIENCE: Risk Manager, Biomedical Engineeing, Cardiology ISSUE: Boston Scientific Corp is recalling RotaWire 'Elite' core wires because they may crack and separate from the rest of the Rotablator Rotational Atheroctomy System and cause serious injury such as tamponade (blood in the sac around the heart causing decreased heart function), myocardial infarction (heart attack), and migration of wire...

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Compounded Multivitamins by Glades Drugs: Voluntary Recall - High Amounts of Vitamin D3 (Cholecalciferol)

November 24, 2015

[Posted 11/25/2015] AUDIENCE: Pharmacy, Health Professional, Patient ISSUE: The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol), distributed nationwide by Glades Drugs in Pahokee, Florida. FDA has received reports of several adverse events potentially associated with...

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Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants

November 17, 2015

Audience: Radiology, Endocrinology, Patient. ISSUE: FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. In all of the reported cases, the infants were either premature or had other serious underlying medical conditions. Available evidence leads FDA to bel...

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Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death

November 6, 2015

Audience: Cardiology, Hematology, Surgery. ISSUE: An FDA review has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. FDA evaluation of the Dual Antiplatelet Therapy (DAPT) trial and several other clinical trials also does not suggest that clopidogrel increases the risk of cancer or death...

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Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery

October 29, 2015

Audience: Pharmacy, Patient. ISSUE: Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate...

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Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks

October 26, 2015

Audience: Neurology. Including Comtan (entacapone) and Stalevo (entacapone, carbidopa, and levodopa) ISSUE: An FDA safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson’s disease. As a result, recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, c...

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Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury

October 22, 2015

Audience: Patient, Infectious Disease, Pharmacy. ISSUE: FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic...

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Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies

October 22, 2015

Audience: Internal Medicine, Nephrology, Cardiology. ISSUE: FDA is requiring the Kayexalate manufacturer to conduct studies to investigate Kayexalate’s potential to bind to other medications administered by mouth – drug interactions that could affect how well the other medications work. The approved labeling for Kayexalate describes its potential to decrease absorption of lithium and thyroxine; however, extensive dr...

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Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance

October 21, 2015

Audience: Consumer, Pharmacy. [Posted 10/21/2015] ISSUE: Downing Labs, LLC is voluntarily recalling all lots of sterile products compounded and packaged by Downing Labs and that remain within expiry due to concerns over sterility assurance. The products were distributed nationwide and in the UK to patients and providers between April 20, 2015 and September 15, 2015. If there is a contamination in products intended...

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Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength

October 15, 2015

Audience: Pharmacy, Consumer. ISSUE: On October 9, 2015, Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level. The Acetaminophen 500mg, Tab 100/BT (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg”. The Acetaminophen ta...

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Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: FDA Statement - Lack of Sterility Assurance

October 2, 2015

Audience: Pharmacy, Compounding, Nursing, Risk Manager. [Posted 10/03/2015] ISSUE: During FDA’s recent inspection of Park Compounding Pharmacy’s facility, FDA investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about the company’s ability to assure the sterility of drug products that it produced. The FDA is alerting health care professionals and patients ...

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Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance

September 24, 2015

Audience: Health Professional, Patient. [Posted 09/24/2015] ISSUE: US Compounding, Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by USC and that remain within expiry due to FDA concern over a lack of sterility assurance. The sterile products were distributed nationwide to patients, providers, hospitals, or clinics between March 14, 2015 and September 9, 2015. If...

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Avycaz (ceftazidime and avibactam): Drug Safety Communication - Dose Confusion and Medication Errors

September 22, 2015

Audience: Infectious Disease, Pharmacy. ISSUE: FDA is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion about the drug strength displayed on the vial and carton labels. Avycaz was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (i.e., 2...

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Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger

September 21, 2015

Audience: Health Professionals. ISSUE:  FDA is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. FDA is evaluating all available information and will communicate final conclusions ...

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Ayurvedic Dietary Supplements by Shree Baidyanath: Consumer Advice Notice - Products Contain High Levels of Lead and/or Mercury

September 17, 2015

Audience: Consumers. [Posted 09/17/2015] ISSUE: Consumers who have used any of the Baidyanath brand Ayurvedic dietary supplements listed in the Consumer Advice Notice should stop using them and consult their health care provider. Testing by the New York Department of Health and the U.S. Food and Drug Administration (FDA) has found that these products contain high levels of lead and/or mercury, which can cause...

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Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program

September 15, 2015

Audience: Psychiatry, Pharmacy, Hematology. ISSUE: FDA is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia. Severe neutropenia is a dangerously low number of neutrophils, white blood cells that help fight infections....

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Miracle Diet 30 and Miracle Rock 48 Capsules by The One Minute Miracle Inc.: Recall - Due to Presence of Undeclared Drug Products

September 11, 2015

Audience: Consumer. ISSUE: The One Minute Miracle Inc. is voluntarily recalling all lots of Miracle Diet 30, capsules and Miracle Rock 48, capsules to the consumer level. These products have been recalled due to FDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs. Miracle Diet 30 has been found to contain undeclared phenolphthalein, phenolphthalein was...

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Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density

September 10, 2015

Audience: Endocrinology, Nursing, Family Practice. ISSUE: FDA has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, and added new information about decreased bone mineral density. To address these safety concerns, FDA added a new WARNING AND PRECAUTION and revised the ADVERSE REACTIONS section of the Invokana and Invokamet...

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Medistat RX Sterile Drug Products: Recall - Possible Contamination

September 10, 2015

Audience: Health Professional, Patient. [Posted 09/10/2015] ISSUE: FDA alerted 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. During an ongoing inspection, FDA investigators and Alabama state inspectors observed significant deficiencies that raise...

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Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning

September 8, 2015

Audience: Pharmacy, Nursing, Risk Manager, Compounding. Alert now includes 1 mL, 10 mL, 20 mL, and 30 mL BD syringes, and BD oral syringes [Posted 09/08/2015] 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...

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