McNeil issues recall at wholesaler level
FORT WASHINGTON, Pa. — In consultation with the Food and Drug Administration, McNeil Consumer Healthcare on Friday voluntarily recalled certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain and Tylenol upper respiratory products, as well as certain lots of Benadryl, Sudafed PE and Sinutab products at the wholesale level.
All of the products were manufactured at the McNeil plant in Fort Washington, Pa., prior to April 2010, when production at the facility was suspended. McNeil stated the company has initiated the recall as a precautionary measure after an extensive review of past production records found instances where equipment-cleaning procedures were insufficient or that cleaning was not adequately documented. However, it is very unlikely that this impacted the quality of these products, McNeil stated.
McNeil also initiated a voluntary recall of certain product lots of Rolaids Multi-Symptom Berry tablets distributed in the United States, in order to update the labeling. The company initiated the recall after determining that the product labeling does not include the language "Does not meet USP" as required by regulation.
Because the recalls are being initiated at the wholesale level, no action is required by consumers or healthcare providers, and consumers can continue to use the product, McNeil stated. These actions are not being undertaken on the basis of adverse events, the company added.
Kentucky introduces PSE Rx legislation
FRANKFORT, Ky. — The battle for the prescription status of methamphetamine precursor/popular cough-cold ingredient pseudoephedrine now is heating up in Kentucky, just a few days following a Nevada news report that suggested the state will be considering PSE prescription-only requirements just as soon as a bill is introduced by Nevada Sen. Sheila Leslie, D-Reno.
Kentucky Reps. Linda Belcher, D-Shepherdsville, and Mary Lou Marzian, D-Louisville, introduced legislation to establish a PSE prescription-only requirement on the first day of the General Assembly — Jan. 4. Kentucky Sen. Tom Jensen, R-London, introduced similar legislation in the Senate.
The Kentucky Legislative Research Commission on Thursday entertained presentations from both sides of the argument, including Mandy Hagan, director of state government relations for the Consumer Healthcare Products Association, who testified on behalf of the industry.
Proponents of the prescription-only solution pointed to the significant reduction in methamphetamine busts in Oregon and Mississippi, two states that currently require prescriptions for PSE purchases, according to a report in the Lexington Herald Leader that covered the meeting.
Proponents of an electronic logging system, such as MethCheck, that currently is up and running in Kentucky, contended that the increase in methamphetamine-related crimes was a direct result of law enforcement’s ability to track PSE sales in real time.
"We are seeing an increase in the number of meth labs [found] because of the information that MethCheck provides," testified Daviess County Sheriff Keith Cain, as reported in the Herald Leader report. "It has proven to be very helpful in tracking individuals who are trying to [buy over-the-counter drugs to produce methamphetamine]."
If pseudoephedrine requires a prescription in the future, buyers would be tracked in Kentucky by the All Schedule Prescription Electronic Reporting system, or KASPER, which tracks every prescription for controlled substances written in the state, Cain continued. There typically is a lag of several days for KASPER reports, compared with the real-time reporting capabilities associated with MethCheck.
However, Kentucky State Police Major Joe Williams testified that most of the meth labs found in Kentucky were not uncovered using MethCheck.
According to the Herald Leader report, Kentucky’s meth lab incidents totaled more than 1,000 in 2010. A report released by the legislature’s Program Review and Investigations Committee identified a 70% decline in the number of meth lab incidents in Mississippi.
ProPhase sponsors ‘Cold-Eeze Skate for the Heart’
DOYLESTOWN, Pa. — ProPhase Labs on Thursday announced its title sponsor of the "Cold-Eeze Skate for the Heart" show, airing on NBC stations Jan. 16 from 4 to 6 p.m., EST.
"We are so proud to support these world-class skaters and the critical heart health cause," stated Ted Karkus, CEO of ProPhase Labs. "We are also huge fans of the amazing singers in the show."
"Cold-Eeze Skate for the Heart" world class skaters include Joannie Rochette, Sasha Cohen, Rachael Flatt, Jeremy Abbott, Johnny Weir and Ryan Bradley, as well as dance and pair figure skaters Tanith Belbin and Ben Agosto, and Caydee Denney and Jeremy Barrett.
The show, which features a dozen world-class ice skaters, as well as vocal group Straight No Chaser and American Idol singers Ruben Studdard and David Archuleta, is dedicated to raising awareness about heart health and the American Heart Association.
The show will be hosted by Olympic medalist Michelle Kwan and Olympic medalist Peggy Fleming, who is a strong advocate for heart health. Fleming’s father suffered a fatal heart attack one week before she won the Olympic Gold Medal. Her sister also recently passed away of a heart ailment.
As part of the title sponsorship of "Cold-Eeze Skate for the Heart," Karkus will be interviewed by skaters Sasha Cohen, Rachael Flatt and Brian Boitano in four spots to be aired during the broadcast. Some of these spots will also air on rebroadcasts on the Hallmark Channel on Feb. 8 and Feb. 15 during National Heart Awareness Month. "Ice-skating viewers fall into our Cold-Eeze core target demographic, so this is a great fit," Karkus said.