Limbrel250 recall: Labeling Error
Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals…
Why was Limbrel250 recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots within expiry.
- Product
- Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals…
- Recalling firm
- Primus Pharmaceuticals, Inc.
- Quantity
- 4,006 bottles
- Distribution
- Nationwide in the USA.
- Recall date
- February 21, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)