Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
FDA recall notice · announced February 7, 2018 · A&h Focal
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The product
Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
Reason for recall
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.
Notes
Distribution: NY and NJ through six retail stores named "Asian Food Markets"
Lot/code information: All Lots
Quantity: unknown
Status: Terminated
Products in this recall event:
- LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language (D-0558-2018)
- HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language (D-0566-2018)
- Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language (D-0561-2018)
- Indian God Lotion Spray Bottle, labeling is in foreign language (D-0553-2018)
- GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language (D-0555-2018)
- LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language (D-0570-2018)
- Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language (D-0552-2018)
- Tiger King tablets, labeling is in foreign language (D-0572-2018)
- Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language (D-0568-2018)
- YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language (D-0567-2018)
- DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language (D-0569-2018)
- Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language (D-0554-2018)
- ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language (D-0562-2018)
- Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language (D-0560-2018)
- GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language (D-0559-2018)
- HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language (D-0557-2018)
- MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language (D-0565-2018)
- GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language (D-0556-2018)
- STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language (D-0564-2018)
- MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language (D-0571-2018)
- Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language (D-0563-2018)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.