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Recall Observatory FDA recall evidence

Drug product

Indian God Lotion Spray Bottle, labeling is in foreign language

D-0553-2018

March 07, 2017

Class III

Product summary

Firm
A&H Focal Inc.
Event
Event 76644
Status
Terminated
Classification
Class III
Quantity
unknown
Official record key
drug-enforcement:D-0553-2018

Official wording

Reason: Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.

Code information: All Lots

Distribution pattern: NY and NJ through six retail stores named "Asian Food Markets"

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.