Pharmaceutical Company Issues Voluntary Recall Of Methocarbamol Tablets Labeled In Wrong Concentration

The United States Food and Drug Administration (FDA) released the following announcement from Bryant Ranch Prepack regarding a voluntary recall of methocarbamol last week. In horses, injectable methocarbamol is FDA-approved for treatment of “acute inflammatory and traumatic conditions of the skeletal muscle to reduce muscle spasm and effect striated-muscle relaxation.” 

Methocarbamol is also sometimes used off-label orally to manage and treat sore backs and muscle strain. Methocarbamol is also prescribed as a prophylactic for horses that experience exertional rhabdomyolysis or “tying up,” which can cause muscle breakdown. Methocarbamol is a depressant and may affect performance and coordination. 

[Story Continues Below]

Bryant Ranch Prepack is voluntarily recalling one lot of methocarbamol 500 mg tablets to the consumer level. The bottles labeled as methocarbamol 500mg tablets have been found to contain methocarbamol 750 mg Tablets.

Risk Statement: If a patient takes a 750 mg tablet of methocarbamol instead of the prescribed 500 mg tablets, it potentially could result in excessive central nervous system depression, which may result in nausea, sedation, fainting, falls, seizure, coma, and death. Bryant Ranch Prepack has not received any reports of adverse events related to this recall.

The product is used together with rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions and is packaged in a white round bottle with a red and white label, which reads methocarbamol 500 mg packaged in counts of 30 (NDC:7133517952), 60 (NDC: 7133517954), and 90 (NDC:7133517957) pills. The affected methocarbamol 500 mg lots include the following Lot Number 163935/ Exp. Date 10/22. The product can be identified by red and white label with a yellow border at the top and bottom of the label, top of the label reads “Packaged by Bryant Ranch Prepack”, labels are pictured below. The methocarbamol 500 mg was distributed nationwide to multiple physician offices.

Bryant Ranch Prepack is notifying its distributors and customers by letter and email and is arranging for return of all recalled products. Consumers that have the bottles labeled as methocarbamol 500 mg tablets which are being recalled should stop using immediately and return to place of purchase and/or contact their physician. Distributors/physicians should stop distribution and contact Bryant Ranch Prepack to return the product immediately.

Consumers with questions regarding this recall can contact Bryant Ranch Prepack by phone at 877-885-0882 Mon.-Fri. 7am-6pm PST or compliance@brppharma.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

The post Pharmaceutical Company Issues Voluntary Recall Of Methocarbamol Tablets Labeled In Wrong Concentration appeared first on Horse Racing News | Paulick Report.

Source of original post

Body & Soul: Hey Sport, How Ya Doin’?

Your correspondent distinctly remembers interviewing a youngish financial guru over lunch at The Palm Court at the Plaza Hotel on Central Park West. It was in 1977, and it was shortly after Seattle Slew won the Triple Crown, something one doesn't forget.

What sticks in our mind, however, was not the interview. Rather he went on a rave about “Slew” after our chat uncovered a mutual obsession with the sport. We tossed out that he might be judged a “freak” by blue-blooded observers, upon which my tablemate provocatively opined that, “No, he's not a freak, he's a 'sport.'”

That caused an eyebrow to arch. We'd come across the term in biology class in college and while subsequently covering a wide variety of sports as a journalist and statistician. However, in 2021 we found this definition in the Macmillan Dictionary: “A sport is a plant or animal that is different in a noticeable way from other plants or animals of the same type.” Not exactly “part of the in-crowd,” maybe a bit of an outlier.

Rather than get into a spat over semantics, our opinion was exactly the opposite: Seattle Slew was what you might imagine would be the result if you bred his fifth dam Myrtlewood to his great grandsire Bold Ruler–he was a replica and thereby the culmination in the perfection of a physical type. He was “part of the in-crowd,” so to speak. But he was no “sport.”

This all comes to mind because of our continual research into how Thoroughbred functionality as expressed in biomechanics and pedigree research can be combined to produce insights into how the breed has evolved and, perhaps, what we can look forward to in the future. In this respect we adhere to the underlying theses set forth by Dr. Franco Varola, by virtue of the titles of his two books: The Typology of the Racehorse (1974) and The Functional Development of the Thoroughbred (1979).

Varola's development of the Dosage system has been misinterpreted by many as a pedigree tool first and foremost. In fact, he developed the system based on how the offspring of stallions performed, what types they produced, how those types functioned, how they influenced the breed typologically–i.e., biomechanically. Along the way the functionality accrued to the pedigrees, but to date there has really been no detailed research into how the two arts (or, scientific arts) have interacted–or could.

We have no issue with pedigree research or utilizing a Dosage system as a basis or supplement to insight. But what sparked our interest of late is that in going through our biomechanical database, we discovered that in the past 30 years there has been one epochal and three additional extraordinary stallions which when they retired to stud were not considered in any biomechanical or pedigree sense “part of the crowd.” They were considered somewhat like outliers. They are their own crowd phenotypically.

A bit of background here: It is axiomatic that a species has a best chance of survival if the breeding population develops leaders whose physical properties adapt to and survive challenges to their environments–ergo, the strong survive. In Thoroughbreds, one wants a balance of power for speed, stride or extension for flexibility, and body weight that neither runs out of gas sprinting (too heavy) or going long (too light).

Phenotype charts tend to place the most consistent breeders close to the center of a target–the more balanced the phenotype, the more likely it will pass on quality.

Our research has shown this to be extremely consistent–indeed, leading sires were usually very well balanced physically and were usually by excellent stallions and had historically successful family trees. Crucially, however, they were of certain types with one or two biomechanical properties that produced runners who could compete at the top levels within the demands of racing programs and market preferences at the time.

For example, the racing programs through the end of the 1970s were geared toward prepping horses for the Classics and handicap races. One of the key properties that was consistent in stallions in those days was that the combination of gears through the hip, or rump if you will, were almost always of the same lengths.

The congruency of these body parts equals balance and strength. If one of them is longer, the function provided by that part of the gears would more than likely help define the racing aptitude of the horse. Up until the 1980s, the only one of those gears that was most often longer than the others was the tibia–whose function was to provide strong, steady closing power–which was what owners of Classic and handicap horses prized.

Beginning in the 1980s and increasingly with the blending of successful European racehorses into North America we saw something more often associated with horses that excelled on the turf–the tibia was shorter than the ilium and femur. This functionality is the biomechanical explanation behind the word “kick.” The shorter the tibia, the more quickly the horse was likely to move late, more likely on the turf at any distance. The longer the ilium, the more pronounced a horse's downhill motion could be generated. The longer the femur, the stronger the thrust toward flexible speed.

Rarely, if ever, had we seen a major commercial sire prospect enter the stud with either the ilium or femur longer or shorter than the tibia–and, more importantly, few of them ever appeared among the leading sires. However, the demands of the marketplace caused breeders to alter their selection processes and, even if they were unaware of biomechanical implications, what happened is that half of the leading lifetime sires of 2020 had “mixed” rear triangles. However, they are almost all completely different from each other phenotypically and most of them are backed by extremely commercial pedigrees.

Then two in 2005 and another in 2012 with completely different pedigrees showed up with rear triangles that were completely different than what we were used to–and they were almost identical to each other phenotypically. Even more remarkable was the fact that they are virtually identical phenotypically to the qualities a previous “sport” brought to the breeding shed in the 1980s. His name was Storm Cat: his rear triangles were evenly balanced but, wow, did they deliver.

Remarkably, none of them look like you would have expected based on their sires or their broodmare sires. None comes from a distaff family that until they came along could have wedged close relatives into select portions of yearling or mixed sales. Functionally as racehorses they were brilliant miler-middle distance types–brilliance accentuated by one or more rear triangle lengths being longer or shorter than the tibia.

Does Medaglia d'Oro remind you of El Prado (Ire) or his broodmare sire Bailjumper?

Does Candy Ride (Arg) remind you of his rangy paternal grandsire Cryptoclearance or his blocky broodmare sire Candy Stripes?

Does Uncle Mo remind you of Indian Charlie or Arch?

Each is his own man, and each reproduces a replica often enough so that he has become an influencer.

Looks like they are making “sports history.”

   Bob Fierro is a partner with Jay Kilgore and Frank Mitchell in DataTrack International, biomechanical consultants and developers of BreezeFigs. He can be reached at bbfq@earthlink.net.

The post Body & Soul: Hey Sport, How Ya Doin’? appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

Source of original post

Verified by MonsterInsights