Home / Recalls / A&H Focal Inc. / D-0553-2018

D-0553-2018 Class III Terminated

Recalled by A&H Focal Inc. — Staten Island, NY

Recall Details

Product Type
Drugs
Report Date
February 7, 2018
Initiation Date
March 7, 2017
Termination Date
June 14, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
unknown

Product Description

Indian God Lotion Spray Bottle, labeling is in foreign language

Reason for Recall

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.

Distribution Pattern

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

Code Information

All Lots

Other recalls by A&H Focal Inc.

  • D-0559-2018 Class I — GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language (March 7, 2017)
  • D-0568-2018 Class I — Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language (March 7, 2017)
  • D-0566-2018 Class I — HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign langua (March 7, 2017)
  • D-0558-2018 Class I — LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in fore (March 7, 2017)
  • D-0571-2018 Class I — MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language (March 7, 2017)
  • D-0561-2018 Class II — Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language (March 7, 2017)
  • D-0564-2018 Class II — STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign languag (March 7, 2017)
  • D-0567-2018 Class I — YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language (March 7, 2017)
  • D-0569-2018 Class I — DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in for (March 7, 2017)
  • D-0552-2018 Class II — Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign langua (March 7, 2017)