Prostamax DUO recall: CGMP Deviations
Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products
Why was Prostamax DUO recalled?
Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
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?
Lot # 140515 Exp. Date 05/18 UPC 850993004055,
- Product
- Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products
- Recalling firm
- Sunset Natural Products Inc.
- Quantity
- 4,000 bottles (240,000 capsules)
- Distribution
- FL and NV
- Recall date
- February 24, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (food)