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Enteric Coated Aspirin 81 mg Tablets by Advance Pharmaceutical Inc.: Recall of One Lot - May Contain Acetaminophen 500 mg Tablets
June 19, 2013
Audience: Consumer, Pharmacy, Health Professional. ISSUE: Advance Pharmaceutical Inc. announced that this firm is conducting a voluntary nationwide recall to the user level of the over-the-counter drug product, Rugby label Enteric Coated Aspirin Tablets, 81 mg, Lot 13A026. Advance Pharmaceutical Inc. first initiated the recall on June 17, 2013, after receiving a complaint about a bottle labeled as Enteric Coated...
Read more...Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication - FDA Investigating Two Deaths Following Injection
June 18, 2013
Audience: Health Professional, Pharmacy, Patient. ISSUE: FDA is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate). The patients died 3-4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation...
Read more...Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections
June 13, 2013
Audience: Patients, Health Professionals. [UPDATE 06/13/2013] FDA identified the specific bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials. See the 06/13/2013 link below for lot numbers and microbial identification information. 6/13/2013 Update on Main Street Family Pharmacy Products [UPDATE 06/07/2013] FDA has...
Read more...Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets
June 12, 2013
Audience: Pharmacy, Patient, Health Professional. ISSUE: Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of Warfarin 2 mg Tablets, Lot #MM5767, expiration date June 2014 to the retail level. Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint. Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological...
Read more...Bethel Nutritional Consulting, Inc. Bethel 30: Recall: Undeclared Drug Ingredient.
June 11, 2013
Audience: Consumer. ISSUE: A sample of Bethel 30 green capsule was collected and tested by FDA and found positive for Sibutramine and Phenolphthalein. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a...
Read more...Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected
June 10, 2013
Audience: Pharmacy, Patient, Health Professional. ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of three lots of Vecuronium Bromide for Injection 10mg (NDC number 25021-657-10) manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and distributed by Sagent. Sagent has initiated this voluntary recall of Vecuronium Bromide for Injection to the user level due to the ...
Read more...Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections
June 7, 2013
Audience: Patients, Health Professionals. [UPDATE 06/07/2013] FDA has identified bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials form Main Street Family Pharmacy. The microbial growth was seen in samples from two separate lots (batches). Additional samples and lots of PF MPA are still under evaluation, as well as other...
Read more...Magnesium Sulfate: Drug Safety Communication - Recommendation Against Prolonged Use in Pre-term Labor
May 30, 2013
Audience: OB/GYN, Nursing, Risk Manager. ISSUE: FDA is advising health care professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in pregnant women. Administration of magnesium sulfate injection to pregnant women longer than 5-7 days may lead to low calcium levels and bone problems in the developing baby or fetus, including thin bones (osteopenia), and fractures. The...
Read more...Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance
May 30, 2013
Audience: Consumer. [Posted 05/30/2013] ISSUE: Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite") notified the public of a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility assurance. In...
Read more...Magnesium Sulfate Injection by Fresenius Kabi USA: Recall - Glass Particles in Vials
May 29, 2013
Audience: Risk Manager, Pharmacy. ISSUE: Fresenius Kabi USA notified health professionals of a voluntary recall of one lot – Lot 6103882 – of Magnesium Sulfate Injection, USP due to the potential presence of glass particles in the vials. The recalled product is labeled with Product Code 6450 and packaged as 500mg/mL strength in 50mL glass vials (25 vials per tray). The product was shipped in the United States...
Read more...Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections
May 28, 2013
Audience: Patients, Health Professionals. [UPDATE 05/28/2013] Main Street Family Pharmacy, LLC has announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy. The compounded products that are subject to the recall are those with a use by date on or before November 20, 2013. The recall is being initiated due to seven (7) reported cases of adverse events in the form of skin...
Read more...Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections
May 24, 2013
Audience: Patients, Health Professionals. ISSUE: The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn. The reports of adverse events are all from patients who received...
Read more...Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials
May 21, 2013
Audience: Pharmacy, Patient, Health Professional. ISSUE: Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. Parenteral injection of drug from the affected lots can...
Read more...Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result
May 20, 2013
Audience: Risk Manager, Patient, Health Professional. [Posted 05/20/2013] ISSUE: Abbott initiated a voluntary recall of FreeStyle lnsulinx Blood Glucose Meters in the United States. At extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Blood Glucose Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. Blood glucose...
Read more...All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance
May 18, 2013
Audience: Pharmacy, Patient, Health Professional. ISSUE: FDA is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA is basing this expanded alert on a recent inspection of the NuVision Dallas facility, during which FDA investigators observed poor sterile production practices that raise...
Read more...Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance
May 17, 2013
Audience: Pharmacy, Patient, Health Professional. ISSUE: Pentec Health, Inc. initiated a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. Pentec Health has received no reports of injury or illness associated with any of the prescriptions subject to this recall. However, because...
Read more...Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses
May 14, 2013
Audience: Family Practice, Health Professional, Patient. Including Ambien, Ambien CR, Edluar, and Zolpimist [UPDATE 05/14/2013] Today, the U.S. Food and Drug Administration (FDA) is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. FDA has approved these changes...
Read more...Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy
May 9, 2013
Audience: Consumer, Health Professional. ISSUE: The nutraceutical company, Xymogen, (Orlando, FL) and FDA, is notifying consumers and health professionals of the recall of Atriphen, a product sold for the support of healthy joint function, because it contains the undeclared allergens, soy and milk. BACKGROUND: Xymogen learned that Atriphen might contain the two allergens, immediately discontinued sale of the...
Read more...SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall - Undeclared Drug Ingredient
May 8, 2013
Audience: Consumer. ISSUE: BeaMonstar Products notified the public that it is recalling its SexVoltz, Velextra, and Amerect capsules to the retail level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled because it has the potential to contain undeclared tadalafil. Tadalafil is an FDA-Approved drug used to...
Read more...The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products
May 8, 2013
Audience: Pharmacy, Healthcare Professionals, Patients. ISSUE: The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products...
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