FDA-Drug2018-02-21Class I
Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-605-16.
Primus Pharmaceuticals, Inc.
Hazard
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Sold states
Nationwide in the USA.
Affected count
4,006 bottles
Manufactured in
7373 N. Scottsdale Rd., Suite B-200, Scottsdale, AZ, United States
Products
Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-605-16.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0346-2018Don't want to check this manually?
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