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FDA MedWatch Alerts

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General Anesthetic and Sedation Drugs: Drug Safety Communication - FDA Approves Label Changes for Use in Young Children

April 27, 2017

Audience: Consumer, Surgery, Anesthesiology. [Posted 04/27/2017] ISSUE: FDA has approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. These changes include: A new Warning stating that exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in...

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Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure

April 25, 2017

Audience: Oncology, Patient, Consumer. ISSUE: FDA issued warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that...

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25 Percent Dextrose Injection, USP (Infant) by Hospira: Recall - Particulate Matter

April 24, 2017

Audience: Pharmacy. ISSUE: Hospira is voluntarily recalling one lot of 25% Dextrose Injection, USP, (Infant) pre-filled syringe to the hospital/user level due to the presence of particulate matter, identified as human hair, found within an internal sample syringe. The affected lot is NDC: 0409-1775-10, Lot 58382EV, Expiry Date 1OCT 2017 In the event that the particulate is administered to a patient, it could result...

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Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength

April 21, 2017

Audience: Pharmacy, Patient. ISSUE: C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer/user level. The manufacturer received a confirmed customer complaint that a bottle labeled as phenobarbital 15 mg was found to contain phenobarbital 30 mg tablets. This mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause...

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Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women

April 20, 2017

Audience: Pediatrics, OB/GYN, Internal Medicine. ISSUE: FDA is restricting the use of codeine and tramadol medicines in children. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine...

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Organic Herbal Supply Supplement Products: Recall - Undeclared Drug Ingredients

April 19, 2017

Audience: Consumer. Including Uproar, Cummor, Zrect, LabidaMAX, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules ISSUE: Organic Herbal Supply, Inc. announced that it is conducting a voluntary nationwide recall of all lots of Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules. FDA...

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Sterile Compounded Products by Isomeric Pharmacy Solutions: Recall - Lack of Sterility Assurance

April 6, 2017

Audience: Patient, Pharmacy. ISSUE: Isomeric Pharmacy Solutions (“Isomeric”) is voluntarily recalling all lots of sterile products compounded and packaged by Isomeric and that remain within expiry to the hospital/user level because of FDA concerns of a lack of sterility assurance. These concerns were brought to Isomeric’s attention during a recent FDA inspection. The sterile products were distributed to patients, pr...

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EpiPen and and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device

March 31, 2017

Audience: Consumer, Pharmacy. ISSUE: Mylan N.V. announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets. This recall is being c...

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LaBri’s Body Health Atomic by Envy Me: Recall - Undeclared Drug Ingredient

March 30, 2017

Audience: Consumer. ISSUE: Envy Me is recalling LaBri’s Body Health Atomic, dietary supplement marketed for weight loss, sold in 60 capsule, plastic bottles. The recall includes all lot codes, manufacturing codes and expiration dates.  The FDA analyzed samples of La Bri’s Body Health Atomic and found it to contain the undeclared ingredient sibutramine. Sibutramine is a controlled substance that was removed from the ...

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Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

March 21, 2017

Audience: Plastic Surgery, Oncology, Patient. ISSUE: FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of b...

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Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

March 15, 2017

Audience: Gatroenterology, Patient. ISSUE: FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive...

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SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus

March 14, 2017

Audience: Risk Manager, Patient. ISSUE: Medtronic is recalling the SynchroMed Implantable Infusion Pumps because a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver large dose of medication from the device to the patient’s spine. During this procedure, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid f...

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Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices

March 9, 2017

Audience: Consumer. ISSUE: Regeneca Worldwide, a division of VivaCeuticals, Inc. is conducting a nationwide recall of its entire line of herbal and dietary supplement products pursuant to a Consent Decree entered by the federal court for the Central District of California. This recall applies to all products manufactured and sold between June 1, 2011 and February 8, 2017. These products include, but are not limited...

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Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient

March 8, 2017

Audience: Consumer. [Posted 03/07/2017] ISSUE: A&H Focal Inc. is voluntarily recalling all lots marketed as dietary supplements for male sexual enhancement from January 2014 to present. These products have been historically tested by the FDA and found to contain PDE-5 Inhibitors (i.e.sildenafil, tadalafil, vardenafil, etc.) which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED),...

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Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance

February 27, 2017

Audience: Urology, Pharmacy, Patient. ISSUE: Endo Pharmaceuticals Inc. is recalling one lot of Edex (alprostadil for injection) 10 mcg to the consumer level. This product recall is due to the detection by Endo of a defect in the crimp caps used in the manufacture of the subject product lot. This defect has the potential to lead to a loss of container closure integrity, which could impact the product’s sterility a...

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Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall - Products May Contain Synthetic or Natural Latex

February 25, 2017

Audience: Pharmacy, Risk Manager. [Posted 02/24/2017] ISSUE: Advanced Pharma, Inc. d/b/a Avella of Houston, is conducting a voluntary recall of all unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location between September 1, 2016 and February 16, 2017 to the user level (hospitals and institutions) because such products may contain synthetic latex an...

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XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient

February 22, 2017

Audience: Consumer. [Posted 02/22/2017] ISSUE: Organic Herbal Supply, Inc. is conducting a voluntary nationwide recall of all lots of XtraHRD Natural Male Enhancement capsules. FDA analysis has found the product to contain Tadalafil. Tadalafil is a FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredients are not listed on the label for this product. Use of this product...

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HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance

February 15, 2017

Audience: Consumer. [Posted 02/15/2017] ISSUE: Synergy Rx Pharmacy recalled all lots of Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial to the retail level due to a lack of sterility assurance. This recall impacts all sterile products distributed between 06/01/2016 and 12/22/2016. The product was only distributed to physician offices and clinics in Arizona, California, Wisconsin, and...

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Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter

February 9, 2017

Audience: Pediatrics, Cardiology, Critical Care Medicine. ISSUE: Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, Inc., is voluntarily recalling lot number PLND1613 of Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL), vials to the hospital or user level. Some of the vials have been found to contain particulate matter. Particulate matter has the potential to block blood vessels, provoke...

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Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids

February 9, 2017

Audience: Consumer, Emergency Medicine. [Posted 02/09/2017] ISSUE: Kingsway Trading Inc. is recalling its 1.06 oz (30g) bottles of “Well Balance Xanthium & Siler Combo (Bi Yan Pian)” Batch No. 130401 & Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item. Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including hea...

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