Hepasil recall: CGMP Deviations
Hepasil, (various bulk amounts)
Why was Hepasil 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 lots and expiration dates: Lot # 400414 Exp. Date 04/17, Lot # 070514 Exp. Date 05/17, Lot # 100614 Exp. Date 06/17, Lot # 110614 Exp. Date 06/17, Lot # 120614 Exp. Date 06/17, Lot # 130614 Exp. Date 06/17, Lot # 140614 Exp. Date 06/17, Lot # 150614 Exp. Date 06/17, Lot # 130515 Exp. Date 03/18, Lot # 190515 Exp. Date 05/18
- Product
- Hepasil, (various bulk amounts)
- Recalling firm
- Sunset Natural Products Inc.
- Quantity
- 2,650,000 capsules
- Distribution
- Products distributed to Florida, Nevada and the Dominican Republic
- Recall date
- January 4, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (food)