FDAFDA · Food and drugs·Recall number D-0346-2018
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.
Published February 21, 2018 · Recall initiated: January 26, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Primus Pharmaceuticals, Inc.
- Distributor
- Nationwide in the USA.
- Lot
- All lots within expiry.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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