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Medicine Recalls

Fusion Health and Vitality LLC is voluntarily recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost Labeling was found to contain statements that 11/23/2020

Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the 11/19/2020

The Cook Fixed Core Wire Guide is a curved wire guide made of stainless steel with non-reactive coating and helps insert medical devices into the body. 11/12/2020

Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use 11/9/2020

Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 - 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who has no 11/9/2020

Laboratories should expect some false positive results when screening large populations with a low prevalence of COVID-19 infection. 11/3/2020

Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues 11/3/2020

Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as publish 11/3/2020

Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit 11/2/2020

Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all Spectrum infusion pumps distributed in the United States, Canada, and the Caribbean, as deviations from the specified cleaning methods may 10/29/2020

Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex? Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 - 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. 10/28/2020

FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications. 10/15/2020 5:00:00 PM

FDA's recommendations to health care providers on giving instructions to patients who self-collect an anterior nares sample for SARS-CoV-2 testing. 10/7/2020

Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of 10/5/2020

Becton Dickinson CareFusion 303, Inc. Recalls Alaris System Pump Module and Pump Module Door Assembly Replacement Kits Due to the Potential for Stuck or Unresponsive Keys 10/2/2020

Ashtel Studios has announced a voluntary recall of all lots of licensed hand sanitizer packaged in .84 oz containers resembling food and drink pouches labeled with various children?s characters listed in the table below to the consumer level. The products are being recalled because they are packaged 10/2/2020

The FDA is providing new information about the risk of NTM infections in patients who have undergone cardiothoracic surgeries using heater-cooler devices. 9/30/2020

Estado de M?xico, M?xico, DMM VISSION, S.A. de C.V. is voluntarily recalling five lots of Cleaner Hand Sanitizer, 500 mL and 1,200 mL plastic clear bottles with white tops currently in US distribution to the consumer level. This recall is being initiated out of abundance of caution due to detection 9/30/2020

Mammography Problems at Allison Breast Center at Monument Radiology 9/25/2020

FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. 9/24/2020 9:19:00 AM

The FDA is providing recommendations for certain high-risk populations may be more vulnerable to potential adverse health effects of mercury exposure from dental amalgam. 9/24/2020

The FDA is requiring the Boxed Warning be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions across all the medicines in the class. 9/23/2020

Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER? (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. The reason for the recall is due to 9/23/2020

Three of the recalls, which BD announced on Aug. 4, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or d 9/21/2020

Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid?, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have 9/17/2020

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