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Medicine Recalls

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

The Alaris System is an infusion system. If parts of the PCA or Syringe Modules are damaged, incorrect syringe details may show, leading to inaccurate infusions. 9/16/2020

The Alaris System is an infusion system. The PC Unit Keys may become stuck or unresponsive and may lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the affected device. 9/14/2020

The Alaris System Infusion Pump is the foundation of the infusion system. Multiple models are being recalled due to damaged IUI Connectors, loose or missing Battery Screws and broken upper and lower hinge posts and membrane frame. 9/14/2020

Medek, LLC is voluntarily recalling all lots of M Hand Sanitizer Alcohol Antiseptic 80% 128 oz/3,785 mL to the consumer level. FDA analysis found the M Hand Sanitizer to contain methanol and be sub-potent for ethanol. Substantial methanol exposure can result in nausea, vomiting, headache, blurred v 9/10/2020

The U.S. Food and Drug Administration (FDA) wants patients and health care providers to know about the risk of injury that may happen to patients if the cold-therapy mode of water-circulating hot/cold therapy devices is not used correctly. 9/9/2020

Miami, Florida. AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level. This lot of bio aaa Advance Hand Sanitizer has been tested and meets all appropriate specifications an 9/3/2020

CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within expiry to the consumer level. The products are being recalled because they are labeled as ?EDIBLE ALCOHOL?. Leafree Hand Sanitizer is an alcohol-based hand rub to be applied externally to reduce bac 9/3/2020

RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid? and WP Thyroid? in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from six (6) lots by the U.S. Food and Drug Administration 9/3/2020

The FDA has reviewed serious side effects associated with implanted spinal cord stimulators. 9/3/2020

The Protein Shoppe, LLC is voluntarily recalling all lots of ?Red-E? (Male Enhancement tablet) to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor which is the active ingred 9/1/2020

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris? System. Three of the situations described in this recall, which BD announced on June 30, 2020, have been designated as Cl 9/1/2020

Gowns purchased from Laws of Motion have potential quality issues and should not be used as personal protective equipment. 8/28/2020 12:14:00 AM

Guadalupe, Nuevo Leon, Harmonic Nature is voluntarily recalling all 800 bottles Hand Sanitizer, 250mL, product due to the potential presence of 1-propanol. The products have been tested and found to contain 1 propanol. Any amount of 1-propanol with a concentration greater than or equal to 1% by v 8/28/2020

Based on FDA's review of new data from three clinical trials, the Boxed Warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) prescribing information was removed. 8/26/2020 9:00:00 AM

Apodaca, Nuevo Leon, Nanomateriales is voluntarily recalling all lots of ZANILAST+ GEL, Sanitizer gel, to the consumer level. FDA laboratory analysis found ZANILAST+ GEL to contain 1-propanol. There is a reasonable probability of acute toxicity from ingestion which can cause central nervous system 8/26/2020

Medfusion 3500 and 4000 syringe pumps control fluid and drug delivery to patients. A software issue may cause over- or under- delivery, causing adverse events. 8/24/2020

The FDA is alerting health care providers and facilities that using protective barrier enclosures when treating COVID19 patients may pose increased health risks 8/21/2020

Bayshore Pharmaceuticals, LLC, Short Hills, NJ is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles within expiry to the consumer lev 8/20/2020

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