FDA Recalls Unapproved Limbrel500 Capsules Marketed Without Approval
Primus Pharmaceuticals is recalling Limbrel500 capsules because they were marketed without FDA approval, meaning their safety and efficacy have not been established.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 per the rubric.
Plain-English summary
Primus Pharmaceuticals, Inc. is recalling Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules. The product is a prescription-only medication manufactured by Cornerstone Research and Development. The recall involves 160,489 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 products are unapproved drugs for which safety and efficacy have not been established.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 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 68040-606-16.
- Manufacturer
- Primus Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 160,489
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
FDA (Drugs) · 2018-02-21
- SeverePrimus Pharmaceuticals Recalls Unapproved Limbrel Flavocoxid Capsules Nationwide
FDA (Drugs) · 2018-02-21
- SeverePrimus Pharmaceuticals Recalls Unapproved Limbrel250 Capsules Nationwide
FDA (Drugs) · 2018-02-21
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