FDA Recalls

FDA RecallsRecalls are actions taken by a company to remove a product from the market. Recalls may be conducted on a company’s own initiative, by FDA request, or by FDA order under statutory authority. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

A market withdrawal occurs when a product has a minor violation that would not be subject to FDA legal action. The company removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

Most Recent FDA Recalls

Pointe Scientific Liquid Glucose Hexokinase Reagent Recall

Pointe Scientific and FDA notified healthcare professionals of a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Distributors and testing laboratories who have received the Liquid Glucose Hexokinase Reagent (G7517) which is being recalled…

American Regent Recalls Ketorolac Tromethamine Injection

American Regent Voluntarily Recalls All Lots of Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 30 mg/mL: NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL) This voluntary recall…

Unomedical Recalls Manual Pulmonary Resuscitators (MPRs)

Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: Unomedical MPR Recall. This…

Philips Recalls Heartstart Fr2+ External Defibrillators

Philips announced today that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by…

FDA Raptiva Recall Statement

Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus…

Cold Therapy Machine – Cryotherapy: FDA Recall

Class A Recall – Polar Care – Medical & Radiation Emitting Device Recalls  Date Posted August 20, 2008 Recall Number N-0015-2008 Product BREG’s Polar Care 500, Part # 02019; Polar Care 500 Lite, Part # 02020; Polar Care 300, Part #28021.Used for cold therapy after orthopedic surgery. Code Information All units of the listed models…

Digitek Digoxin Recall

At this time our law firm is no longer accepting new cases involving this drug. This does not mean that you do not have a case; please seek a second opinion with local legal counsel to discuss your options. The drug manufacturer Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of…