Category Archives: Food & Drug Recalls

Gerber is Voluntarily Recalling Two Batches of GERBER® Organic 2ND FOODS® Pouches Due to a Packaging Defect That May Result in Product Spoilage

Gerber Products Company is voluntarily recalling specific Organic pouch products after identifying a packaging defect that may result in product spoilage during transport and handling. Because of our commitment to high quality, Gerber is working to retrieve from retailers and online stores the remaining pouches from the four affected batches of GERBER® Organic 2ND FOOD pouches that fail to meet our quality standards. We are offering replacement coupons for consumers who purchased the following products:

FDA takes important step to increase the development of, and access to, abuse-deterrent opioids

The U.S. Food and Drug Administration today issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.

FDA approves Cinqair to treat severe asthma

The U.S. Food and Drug Administration today approved Cinqair (reslizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. Cinqair is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. Today’s actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.