Primus Pharmaceuticals Recalls Unapproved Limbrel Flavocoxid Capsules Nationwide
Primus Pharmaceuticals is recalling Limbrel (flavocoxid 500 mg) capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Primus Pharmaceuticals, Inc. is recalling Limbrel (flavocoxid 500 mg) capsules, 60-count bottles, prescription only. The product was manufactured by Cornerstone Research and Development. The recall covers 135,277 bottles distributed nationwide in the USA.
The FDA is recalling these products because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). According to the agency, the safety and efficacy of these unapproved drugs have not been established.
Consumers who have Limbrel capsules should stop using them and contact their healthcare provider or pharmacist for guidance. The recall applies to all lots within the expiration date.
The recalled product
- Product
- Limbrel (flavocoxid 500 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 68040-602-16.
- Manufacturer
- Primus Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 135,277
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Primus Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Primus Pharmaceuticals, Inc.
See all →- SevereFDA Recalls Unapproved Limbrel Flavocoxid Capsules Nationwide
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