Abte, bulk capsules recall: CGMP Deviations
Abte, bulk capsules
Why was Abte, bulk capsules 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 manufactured 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?
As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lot and expiration date: Lot # 040714 Exp. Date 07/17
- Product
- Abte, bulk capsules
- Recalling firm
- Sunset Natural Products Inc.
- Quantity
- 60,000 capsules
- Distribution
- Products distributed to Florida, Nevada and the Dominican Republic
- Recall date
- January 4, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (food)