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What Should I do if My Medication is Recalled?

When a drug on the market is determined to be dangerous in some way, it may be recalled. This can be because the drug was not advertised properly, because a specific batch or all of the drug available is contaminated or compromised, new side effects are discovered, or because the drug in the packages on the market is not the drug labeled on the packages. If a drug you currently take is recalled, stop taking it and contact your healthcare provider or local pharmacy for further instruction. Recalls exist to remove potentially harmful products from the market.

A defective drug claim is a type of personal injury claim. Through this type of claim, a victim can seek compensation for his or her medical expenses, lost wages, and pain and suffering damages related to the use of a harmful drug. If you were given a drug after it was recalled or were harmed by taking a dangerous drug that should have been recalled, you could have grounds to file this type of claim.

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The United States Food and Drug Administration (FDA) announced this week that the agency has filed a consent decree against a medical device manufacturer for repeatedly failing to correct identified violations related to an implantable drug infusion pump. A consent decree is a type of legal settlement in which the manufacturer agrees to follow the court-ordered directives without acknowledgement of fault or guilt. The decree will remain in force until regulators are convinced that the company has addressed and fixed the identified issues.

The SychroMed II Implantable Infusion Pump System is a device designed to deliver medication necessary for the treatment of cancer, chronic pain, and sever spasticity. Medtronic, the manufacturer of the device, says that more 230,000 patients have used a SynchroMed system since it was developed more than 25 years ago. However, inspections by the FDA in 2006 and 2013 identified “significant violations” of federal regulations, including issues related to handling complaints and corrective actions. A warning letter from the FDA in 2012 noted the devices' propensity to stall and subsequently fail to deliver the needed medication.

Finally, in 2013, Medtronic officially notified doctors of several potential problems with the device, revealing that 14 deaths had been associated with the pump. In response, Class 1 recalls were issued to correct the problems, along with promises from the maker to correct the problems. The FDA continued to pursue the action which was made official this week as “defendants are well aware that their practices violate the [Food, Drug, and Cosmetic] Act,” the filing stated. Despite numerous warnings, the administration was not convinced the manufacturer had taken the necessary corrective steps.

Tagged in: Fda Recall

A state inspection of a pharmacy in Fayetteville, North Carolina, has led to the recall of more than 600 drugs in a variety of dosages and formulations, officials announced in late March. The U.S. Food and Drug Administration (FDA) and the North Carolina Board of Pharmacy (NCBOP) have issued a warning to medical professionals and patients regarding all compounded drugs made or distributed by the Prescription Center pharmacy, which has been since shut down.

Compounded Drug Recall

The NCBOP said in a news release that it was recalling all nonsterile and sterile products that were compounded, repackaged, and distributed by the pharmacy from September 10, 2014 to March 10, 2015. The listing of recalled products includes antidepressants, antibiotics, antiviral medications, immunosupressants, and others which were distributed to all 50 states and Canada. “This recall is due [to] the pharmacy's inability to ensure sterility, stability, and potency for these products,” the Board of Pharmacy said. While no complaints of injuries have been received by the board, the NCBOP and FDA are advising clinicians to quarantine any products from the Prescription Center and not to administer them to human or animal patients.

Tagged in: Drugs Fda Recall

When discussing the safety of medical devices or prescription drugs, it is not uncommon to hear about various recalls and safety alerts being issued. The announcement of a safety recall by manufacturers or government regulators may seem extremely ominous, but it is important to understand that a recall does not necessarily mean a product cannot be used at all. There are various types and levels of recalls, and the action required by each is often dependent on the danger related to the particular device or drug.

Recall Classes

The United States Food and Drug Administration (FDA) maintains three separate classes of recalls to be used appropriately based on the level of risk associated with the recalled item. A recall is categorized by the FDA as one of the following:

Tagged in: Recall

The U.S. Food and Drug Administration (FDA) issued its largest recall of medical products ever in 2014, according to the Regulatory Affairs Professional Society (RAPS). The recall, posted to the FDA's website in August, was of 233 Class I products manufactured by Puerto Rico-based Customed.

The FDA classifies medical devices and products into three categories: Class I have the least potential to harm a user—Class III products are usually those that sustain life. Class I examples can include bandages, enema kits, and any medical product not necessary to keep a person's vital organs functioning. Nearly half of all medical products on the market are classified into Class I, according to the FDA.

The devices recalled by Customed were recalled because of packaging flaws. The products were primarily sterile convenience packs; the recall was initiated because of “adhesion in the sterile packaging,” according to RAPS. If the product was used on a patient, it had the potential to not be sterile and lead to infection, though as of September, no cases had been discovered of a person suffering an infection or side effects because of Customed products. The FDA generally does not wait until a case of injury has been discovered to recall medical products; once the manufacturer is aware of the problem, it is responsible to initiate a recall immediately.

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