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.
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.
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