Staten Island, NY, United States
A&H Focal Inc. recalls
1 recall recorded since 2018, most recently on 7 March 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I, Class II, Class III Drugs
- Recall started
- 7 March 2017
- Terminated
- 14 June 2019
- Reason
- Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- Distribution
- NY and NJ through six retail stores named "Asian Food Markets"
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0563-2018, D-0558-2018, D-0566-2018, D-0561-2018, D-0553-2018, D-0555-2018, D-0570-2018, D-0552-2018, D-0572-2018, D-0568-2018, D-0567-2018, D-0569-2018 and 9 more
- Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
- LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language
- HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language
- Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language
- Indian God Lotion Spray Bottle, labeling is in foreign language
- GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language
- LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language
- Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
- and 13 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.