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Recall D-1296-2022

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

Recall D-1296-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1296-2022
Event ID90627
DistributionNationwide within the U.S.A.
Quantity35,622 cartons
Recall ReasonMarketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Drug ClassificationClass I
Drug Code Info20220727
Recall Initiation Date20220526
Report Date20220727
Classification Date20220727
Address2021 7th Ave
Seattle, WA 98121-2601
United States
Recalling FirmAmazon.com, Inc.
Initial Notification E-Mail
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