jueves, 25 de mayo de 2017

FDA MedWatch - Al-Er-G Capsules by MusclMasster: Recall - Contains Banned Substance Ephedra

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Al-Er-G Capsules by MusclMasster: Recall - Contains Banned Substance Ephedra

AUDIENCE: Consumer
ISSUE: MusclMasster, LLC is recalling all bottles of Al-Er-G Capsules. During a recent FDA inspection, it was discovered that this product contained Ephedra Herb, an FDA banned ingredient. Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death, and that these risks are unreasonable in light of any benefits that may result from the use of these products under their labeled conditions of use.
BACKGROUND: This item is packed in a white bottle with a white cap. Each bottle contains 60 or 150 capsules, each capsule is 180 mg of ephedra herb in a 650 mg capsule. This product was distributed from Colorado, through the MusclMasster wellness center and retail store and does not contain UPC codes or expiration dates. The company's lot number is 314. Also one bottle each was shipped to WY, SC, and WA between 2016 and 2017. Al-Er-G was not sold on-line. The company has ceased production and distribution of the product and destroyed 100% of the banned product.
RECOMMENDATION: Consumers who have purchased the product are urged to return them to New Genesis Health, 4565 Kipling Street, Wheat Ridge, CO 80033 for a full refund. Consumers with questions may contact the company at (800) 765-4372 Monday-Friday 9am-6pm MST.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • 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
Read the MedWatch safety alert, including a link to the press release, at:

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