Key Takeaway

Indian God Lotion Spray Bottle, labeling is in foreign language by A&H Focal Inc. was recalled on March 7, 2017. The hazard: Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release...

FDA Drug Class III Terminated

Indian God Lotion Spray Bottle, labeling is in foreign language

Recalled: March 7, 2017 ~unknown units affected D-0553-2018

Description

Indian God Lotion Spray Bottle, labeling is in foreign language

Hazard / 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.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

Indian God Lotion Spray Bottle, labeling is in foreign language

Drugs

Company Information

A&H Focal Inc.

Staten Island, NY, United States

View all 21 recalls by A&H Focal Inc. →

Distribution

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

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.