Primus Pharmaceuticals Recalls Unapproved Limbrel250 Capsules Nationwide
Primus Pharmaceuticals is recalling 4,006 bottles of Limbrel250 capsules because the product was marketed without an approved NDA or ANDA, meaning its 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 source text explicitly identifies the agency classification as Class I. Per the rubric, an FDA Class I recall mandates a severity score of at least 4 (Severe), as it represents a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Primus Pharmaceuticals, Inc. is recalling 4,006 bottles of Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules. The product is a prescription-only medication manufactured by Cornerstone Research and Development. The recall covers all lots within their expiry dates and the product was distributed nationwide in the USA.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). According to the FDA, these products are considered unapproved drugs for which safety and efficacy have not been established.
Consumers who have purchased Limbrel250 capsules should stop using the product and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The recall is classified as Class I by the FDA.
The recalled product
- Product
- 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.
- Manufacturer
- Primus Pharmaceuticals, Inc.
- Affected units
- 4,006
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
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