FDA Recall D-1296-2022
Amazon.com, Inc. · Seattle, WA
Class I — life-threatening Terminated 166 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P. 33880, ASIN B084L2XM3Z, UPC 3166557819586
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Recall record
- Recall number
D-1296-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide within the U.S.A.
- Recall initiated
- 2022-05-26
- Classified by FDA Center
- 2022-07-27
- FDA published
- 2022-07-27
- Terminated
- 2022-11-08
- Recalling firm
- Amazon.com, Inc.
- Firm location
- Seattle, WA