Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: 040 19, Exp. 09 FEB 2025
Where it was sold
Nationwide within the U.S.A.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1296-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 26, 2022
- FDA report date
- Jul 27, 2022
- Quantity
- 35,622 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amazon.com, Inc.
Original FDA data
Every field from FDA enforcement report D-1296-2022, exactly as published.
Show all FDA fields
- City
- Seattle
- State
- WA
- Status
- Terminated
- Country
- United States
- Event ID
- 90627
- Address
- 2021 7th Ave
- Code information
- Lot #: 040 19, Exp. 09 FEB 2025
- Postal code
- 98121-2601
- Report date
- Jul 27, 2022
- Product type
- Drugs
- Recall number
- D-1296-2022
- Classification
- Class I
- Recalling firm
- Amazon.com, Inc.
- Product quantity
- 35,622 cartons
- Termination date
- Nov 8, 2022
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- May 26, 2022
- Initial firm notification
- Center classification date
- Jul 27, 2022