Indian God Lotion Spray Bottle, Labeling Is in Foreign Language
What you need to know
Class III
What happened
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,…
Health risk
The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. A safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.
Action required
Stop applying or using the product. Check the UPC and lot codes below, then return it to the retailer or contact the manufacturer about a refund or replacement.
Recall closed · classified by the FDANY, NJMore cosmetics
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NY and NJ through six retail stores named "Asian Food Markets"
United States
Quantity affected
Not provided by the FDA.
Recall initiation
FDA report date: February 7, 2018
FDA recall number
D-0553-2018
Beyond the headline
The recall, in context
A&h Focal INC. initiated this cosmetics recall on March 7, 2017. The FDA enforcement report states: 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. The FDA report lists distribution as: NY and NJ through six retail stores named "Asian Food Markets".
The FDA enforcement report describes the reason as: 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.
Indian God Lotion Spray Bottle, Labeling Is in Foreign Language was made or distributed by A&h Focal INC. in Staten Island, NY, United States. This page reflects FDA report D-0553-2018, dated February 7, 2018.
Why this is a Class III recall
Class III means the product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. In this recall, a safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.
FDA definition
The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations.
What to do now
1
Stop using it
Set the product aside and do not apply it.
2
Check the codes
Compare the lot and date codes against the table above.
3
Return or discard
Contact the retailer or recalling firm about a refund, and dispose of the product safely.
Consumer safety guide
Product safety recall
Symptoms to watch for
The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.
Higher-risk groups
Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.
What to do now
1Stop using or eating the product and keep it away from children and pets.
2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
3Seek medical advice if anyone develops severe or worrying symptoms after exposure.
Read the official source record for the specific hazard and instructions.
This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.
Frequently asked
Questions about this recall
4 answers
What is the Indian God Lotion Spray Bottle, Labeling Is in Foreign Language recall?
A&h Focal INC. recalled Indian God Lotion Spray Bottle, Labeling Is in Foreign Language in an FDA Class III enforcement action reported as D-0553-2018. 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,…
What should I do if I bought this product?
Stop applying or using the product. Check the UPC and lot codes below, then return it to the retailer or contact the manufacturer about a refund or replacement. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.
Is the A&h Focal INC. recall still active?
The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.
Where can I verify this recall?
This page is normalized from the openFDA enforcement record D-0553-2018. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.
Verify before you act.
VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.