Oxymorphone hydrochloride (Opana ER) - Request to Remove from Market
An FDA advisory committee concluded the risks of oxymorphone ER now outweigh the benefits of use.... Read More
Pharmacy Services Alerts
Alerts
Recall of Ticagrelor (Brilinta) Physician Sample Bottles
AstraZeneca is voluntarily recalling ticagrelor (Brilinta) 90 mg physician sample bottles because they may also contain lesinurad (Zurampic) 200 mg tablets, another AstraZeneca product.... Read More
Mibelas 24 Fe Chewable Tablets Packaging Error and Recall
Lupin Pharmaceuticals Inc. recalled lot L600518, expiry 05/18 of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol 1 mg/0.02 mg and ferrous fumarate 75 mg) chewable tablets.... Read More
Canagliflozin Products (Invokana and Invokamet) Cause Increased Risk of Lower Limb Amputations
A new black-box warning for risk of leg and foot amputations is required for canagliflozin-containing products.... Read More
GEC Laxoplex Dietary Supplement by Genetic Edge Compounds Recall
Genetic Edge Compounds is voluntarily recalling GEC Laxoplex due to FDA concerns regarding the presence of anabolic steroids and other steroid-like substances.... Read More
Hospira 25% Dextrose Injection, USP (Infant) pre-filled syringe – Recall Due to Particulate Matter
Hospira Inc., is voluntarily recalling one lot (NDC 0408-1775-10, Lot # 58382EV) of 25% Dextrose Injection, USP (Infant) prefilled syringes.... Read More
Tramadol and Codeine –New Contraindications and Warnings Regarding Risk of Serious Breathing Problems and Death in Pediatric Patients - UPDATED
The FDA previously issued warnings regarding the use of tramadol and codeine in children due to the risk of serious breathing problems and death.... Read More
General Anesthetic and Sedation Drugs: New Warnings for Young Children and Pregnant Women – Updated
FDA approved a new warning in the product labeling reflecting this risk.... Read More
Illegal Cancer Products - Fraudulent Claims of Cancer Prevention, Diagnosis, Treatment, or Cure
FDA is warning consumers and health care professionals that several companies have sold products illegally claiming to prevent, diagnose, treat, or cure cancer.... Read More
Epoetin alfa, Darbepoetin alfa: Discontinuation of the Apprise Risk Management Program (REMS)
The FDA has discontinued the Risk Evaluation Mitigation Strategy (REMS) program for the erythropoiesis-stimulating agents (ESAs).... Read More
Homeopathic Teething Tablets and Gels - Potential Risk of Harm to Infants and Children - Updated
FDA issued a warning about the risk of adverse effects from all homeopathic teething tablets and gels. The company has agreed to conduct a recall of their belladonna homeopathic teething products as of April 2017.... Read More
Eluxadoline (Viberzi®) May Cause Serious Pancreatitis in Patients Without a Gallbladder
Eluxadoline (Viberzi®) may cause serious, life-threatening pancreatitis in patients without a gallbladder.... Read More
Well Balance Xanthium & Siler Combo (Bi Yan Pian) by Kingsway Trading Inc.
Kingsway Trading Inc. is recalling its dietary supplement Well Balance Xanthium & Siler Combo (Bi Yan Pian) due to the presence of ephedra herba (ma huang) in the product.... Read More
Chlorhexidine Gluconate – Anaphylaxis Warning Added to Over-the-Counter Drug Facts Label
Due to increases in reports of anaphylaxis, a warning is now being added to the OTC Drug Facts labels.... Read More
Implantable Infusion Pump Safety Concerns – Caution in Magnetic Resonance (MR) Environments
FDA is informing patients and health care professionals that magnetic resonance (MR) environments can cause implantable infusion pump errors resulting in patient harm and death.... Read More
Vascu-Guard Patch Risk of Severe Bleeding Complications
FDA received a cluster of bleeding event reports in 2016 associated with the Vascu-Guard Peripheral Vascular Patch from Baxter International. ... Read More
Opioid Use with Benzodiazepines – New Boxed Warning for Risks of Concomitant Use
FDA is adding a new boxed warning to all opioid medications and benzodiazepines about the risk of serious adverse effects with concomitant use. FDA reviewed 6 studies regarding opioid use with benzodiazepines.... Read More