Primus Pharma Limbrel Medical Food Recall [US]


US FlagUS/Silver Spring: Primus Pharma Limbrel Medical Food Recall [US]Primus Pharmaceuticals, Inc., a Scottsdale, Arizona establishment, recalls all unexpired batch/lots of Limbrel Medical Food products due to suspected
rare but serious and side effects, all serious health hazard. FDA: http://ht.ly/zotI30i64Fy

Direct link: https://www.fda.gov/Safety/Recalls/ucm594357.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Limbrel Medical Food products are subject to this recall:

  • Limbrel (Flavocoxid) 250 mg capsules, Product Identity Number 68040-601-16
  • Limbrel250 (250 mg Flavocoxid with 50 mg Citrated Zinc Bisglycinate) capsules, Product Identity Number 68040-605-16
  • Limbrel (Flavocoxid) 500 mg capsules, Product Identity Number 68040-602-16
  • Limbrel500 (500 mg Flavocoxid with 50 mg Citrated Zinc Bisglycinate) capsules, Product Identity Number 68040-606-16

Please consult the photograph above for details of the food’s packaging, design and retail presentation. Additional image of the recalled Medical Food can be found on the Web site above.

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, between January 1, 2007, and November 9, 2017, FDA received 30 adverse event reports of elevated liver function tests or Acute Hypersensitivity Pneumonitis associated with the use of Limbrel products

These conditions present in rare cases with varying degrees of severity in patients taking Limbrel for the first time in the initial weeks of exposure, and may go unnoticed by the patient until they consult with their physician or until symptoms develop that require hospitalization. There have been no deaths reported with the use of Limbrel, and in all reported cases adverse effects resolved without residual effects after discontinuing use of the product.

If you believe you have purchased or have in your possession any of the recalled medication, please do not consume them directly nor use them as an ingredient in another dish or preparation. Instead, return the Limbrel Medical Food products to the pharmacist or dispensary where you acquired it for a full refund.

If you have any questions about this recall, please contact Primus Pharma by calling 1-480-483-1410 from 9:00 AM to 5:00 PM Mountain Standard Time.

==> To see other recalls and notifications caused by suspected contaminated, adulterated or mislabeled Medical Food, please search for “Medical Food” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Primus Pharmaceuticals, Inc, please search for “Primus” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 9721-2018
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

We welcome your feedback:
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E. & O. E.

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