Tag: Robaxin

What You Should Know Before You Take Robaxin ?

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of methocarbamol in children below 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methocarbamol in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

      • Alfentanil
      • Alprazolam
      • Amobarbital
      • Aprobarbital
      • Benzhydrocodone
      • Bromazepam
      • Buprenorphine
      • Butabarbital
      • Butalbital
      • Butorphanol
      • Calcium Oxybate
      • Cannabidiol
      • Carisoprodol
      • Cetirizine
      • Chloral Hydrate
      • Chlordiazepoxide
      • Chlorzoxazone
      • Clobazam
      • Clonazepam
      • Clorazepate
      • Codeine
      • Dantrolene
      • Daridorexant
      • Diazepam
      • Dihydrocodeine
      • Doxylamine
      • Esketamine
      • Estazolam
      • Ethchlorvynol
      • Fentanyl
      • Flibanserin
      • Flunitrazepam
      • Flurazepam
      • Gabapentin
      • Gabapentin Enacarbil
      • Halazepam
      • Hydrocodone
      • Hydromorphone
      • Ketamine
      • Ketazolam
      • Lemborexant
      • Levocetirizine
      • Levorphanol
      • Lofexidine
      • Lorazepam
      • Lormetazepam
      • Loxapine
      • Magnesium Oxybate
      • Medazepam
      • Meperidine
      • Mephenesin
      • Mephobarbital
      • Meprobamate
      • Metaxalone
      • Methadone
      • Methohexital
      • Metoclopramide
      • Midazolam
      • Morphine
      • Morphine Sulfate Liposome
      • Nalbuphine
      • Nitrazepam
      • Oxazepam
      • Oxycodone
      • Oxymorphone
      • Pentazocine
      • Pentobarbital
      • Periciazine
      • Phenobarbital
      • Potassium Oxybate
      • Prazepam
      • Pregabalin
      • Primidone
      • Quazepam
      • Remifentanil
      • Remimazolam
      • Ropeginterferon Alfa-2b-njft
      • Scopolamine
      • Secobarbital
      • Sodium Oxybate
      • Sufentanil
      • Tapentadol
      • Temazepam
      • Thiopental
      • Tramadol
      • Trazodone
      • Triazolam
      • Zolpidem

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

      • Kidney disease or
      • Liver disease—Use with caution. The effects of this medicine may be increased because of slower removal from the body.
      • Myasthenia gravis—Use with caution. May make this condition worse.

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as “two to four tablets four times daily” rather than the correct dosage of “two tablets three times daily.” (see picture below for location of incorrect text).

Patients who follow the directions on the bottle may experience significant drowsiness or dizziness which would put them at risk of falls or an overdose which could result in seizures, coma, or death. To date, Endo Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

Robaxin® 750mg Tablets contain the active ingredient methocarbamol and are indicated as an adjunct therapy to rest, physical therapy and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. Robaxin® 750mg Tablets are packed in bottles of 100 tablets with package labeling featuring the product name, strength, lot number, expiry date and the National Drug Code number NDC 52244-449-10.

The recall includes the following product lots:

    • Robaxin® 750mg, 100 Count Bottle pack, Lot 216702P1, Expiration Date: September 2020; and
    • Robaxin® 750mg, 100 Count Bottle pack, Lot 220409P1, Expiration Date: January 2021.

No other lots of Robaxin® are affected by this market action.

Robaxin® 750mg 100 Count Bottle packs were distributed by wholesale distributors to retail pharmacies.

Endo Pharmaceuticals Inc. is notifying distributors and retailers in writing through Inmar, Inc. Inmar is arranging for return of all recalled products.

Distributors and retailers that have product which is being recalled should stop distributing and dispensing and return to the place of purchase.

Consumers in possession of any unused prescribed Robaxin® 750mg product bearing lot numbers 216702P1 or 220409P1 should discontinue use of the product and return the unused product by following the instructions below:

  • Please contact Inmar at 1-866-391-0620, Monday through Friday (9am to 5pm ET) or email robaxin@inmar.com for the following:
    • Product Return
      • Upon contacting Inmar and indicating you have unused product, please expect Return Authorization labels and Shipping instructions.
    • Product Reimbursement
      • Upon contacting Inmar, please be prepared to share proof of purchase.
        • Proof of purchase can be sent to robaxin@inmar.com or 635 Vine St.Winston Salem, NC 27101-Attention Recall Department, Robaxin Recall.

Distributors, retailers and consumers with questions regarding this recall can contact Inmar by telephone at 1-866-391-0620 during the following hours: Monday through Friday (9am to 5pm ET) or by email at robaxin@inmar.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 associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

  • Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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 Product Recall is being made with the knowledge of the United States Food and Drug Administration (FDA).

Endo Pharmaceuticals Inc. takes this issue seriously and works to achieve high quality standards for all of its products and packaging. If you have any questions, please call 1-800-462-ENDO (3636), between the hours of 8:00 a.m. to 8:00 p.m. ET Monday through Thursday and 8:00 a.m. to 6:00 p.m. ET on Friday. Additional information regarding this recall can be found at http://www.endo.com/endopharma/our-products.