Recalls / Class III
Class IIID-0553-2018
Product
Indian God Lotion Spray Bottle, labeling is in foreign language
- Affected lot / code info
- All Lots
Why it was recalled
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.
Recalling firm
- Firm
- A&H Focal Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 119 Linwood Ave, Staten Island, New York 10305-4445
Distribution
- Quantity
- unknown
- Distribution pattern
- NY and NJ through six retail stores named "Asian Food Markets"
Timeline
- Recall initiated
- 2017-03-07
- FDA classified
- 2018-02-28
- Posted by FDA
- 2018-02-07
- Terminated
- 2019-06-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0553-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.