Amazon.com, Inc.: Drug Recall
Recall #D-1296-2022 · 05/26/2022
Class I: Dangerous
Recall Details
- Recall Number
- D-1296-2022
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Amazon.com, Inc.
- Status
- Terminated
- Date Initiated
- 05/26/2022
- Location
- Seattle, WA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,622 cartons
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Product Description
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
Distribution Pattern
Nationwide within the U.S.A.
Other Recalls by Amazon.com, Inc.
- Class I: Dangerous 05/26/2022
- Class I: Dangerous 05/26/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.