The U.S. Food and Drug Administration (FDA) is categorizing Medtronic’s septostomy catheter recall as Class I. A Class I medical device recall is the most serious, meaning that use of the medical device could cause serious injuries or death. Here is what we know about the recall. Medical Device Recall...
Are There Flaws in the FDA’s Medical Device Evaluation Process?
Before they can be used on patients, medical devices must be approved by the U.S. Food and Drug Administration (FDA). Recently, the question has been raised of if there are flaws in the FDA’s medical device evaluation process? Researchers at Yale School of Medicine think there are. According to a...
FDA Warning: NSAID Use During Pregnancy Could Cause Complications
The U.S. Food and Drug Administration (FDA) has released a drug safety warning about the use of nonsteroidal anti-inflammatory drugs (NSAIDs) during pregnancy. According to the FDA warning, using NSAIDs after the 20th week of pregnancy could cause serious kidney problems in the unborn infant. The FDA notes that healthcare...
Diabetes Drug Recall Expands due to Excess Levels of Cancer-Causing Agent
Over the past several months, a number of Metformin recalls have caused concern and near-panic in the healthcare community and among consumers. Various batches of Metformin have been recalled due to containing higher-than-acceptable levels of the carcinogen N-Nitrosodimethylamine (NDMA). Now, the already significant diabetes drug recall has expanded once again....
Another Thyroid Medication Recall Due to Sub Potency
The U.S. Food and Drug Administration (FDA) has announced another thyroid medication recall due to the drugs being sub potent. This FDA recall includes two lots of medication manufactured by Acella Pharmaceuticals, LLC. The Acella recall follows just weeks after RLC Labs, Inc. announced a hypothyroidism medication recall of certain...
Bayer Agrees to Pay $1.6 Billion in Essure Injury Settlements
Pharmaceutical giant Bayer has agreed to pay $1.6 billion in Essure injury settlements. Tens of thousands of women have reported that the medical device caused injuries after insertion. The settlement may be a relief for many women, but it appears that Bayer is not planning to offer an apology for...
Hypothyroidism Medication Recall Issued due to Sub Potency
The U.S. Food and Drug Administration (FDA) has announced a medication recall of certain hypothyroidism medications. This is just one of several recent FDA recalls relating to sub potency of the medication. That means that patients taking the medication may not get the full benefit of the drug or the...
FDA Issues New Contaminant Warning Related to Hand Sanitizers
We are still in the midst of the COVID-19 pandemic. With schools across the country reopening, families are more concerned than ever with hand hygiene. Hand sanitizers are one of the top selling items during back to school season. This year, however, parents may have to stay away from the...
Another Metformin Recall Due to Carcinogen Concerns
The U.S. Food and Drug Administration (FDA) has identified yet another metformin recall due to higher-than-acceptable levels of carcinogen N-Nitrosodimethylamine (NDMA). This marks the sixth drugmaker to recall metformin and pull lots from the market. Here is our continuing coverage of this medication recall. Another Metformin Recall Due to Carcinogen...
Alaris System Infusion Pump Recall Includes 774,000 Units
Becton Dickinson (BD) CareFusion 303 Inc. is recalling certain lots of Alaris System Infusion Pumps due to system and software errors. The recall includes around 774,000 units. The U.S. Food and Drug Administration (FDA) has classified the recall as Class I, the most serious classification of recall. A Class I...
Sundial Herbal Products Recalled as ‘Unapproved Drugs’
If you regularly purchase herbs and supplements as part of your healthcare regimen, take note of this massive recall! Sundial Herbal Products is recalling all of their products with a manufacture date of 2014 or later. The recall follows the U.S. Food and Drug Administration (FDA) deeming them “unapproved drugs.”...
FDA List Now Includes 75 Toxic Hand Sanitizers
In June we told you about the U.S. Food and Drug Administration (FDA) urging consumers to avoid certain hand sanitizers that may contain methanol. Now, the FDA is including at least 75 hand sanitizers in their warning to consumers. The toxic hand sanitizers pose a serious risk to consumers. While...