FDA Recall
Terminated
Historical recordClass I
HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
View recall →
FDA Recall
Terminated
Historical recordClass II
MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
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FDA Recall
Terminated
Historical recordClass II
STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
View recall →
FDA Recall
Terminated
Historical recordClass I
Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
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FDA Recall
Terminated
Historical recordClass I
ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
View recall →
FDA Recall
Terminated
Historical recordClass II
Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
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FDA Recall
Terminated
Historical recordClass I
Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
View recall →
FDA Recall
Terminated
Historical recordClass I
GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
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FDA Recall
Terminated
Historical recordClass I
LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
View recall →
FDA Recall
Terminated
Historical recordClass II
HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
View recall →
FDA Recall
Terminated
Historical recordClass I
GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
View recall →
FDA Recall
Terminated
Historical recordClass I
GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
View recall →
FDA Recall
Terminated
Historical recordClass I
Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
View recall →
FDA Recall
Terminated
Historical recordClass III
Indian God Lotion Spray Bottle, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
View recall →
FDA Recall
Terminated
Historical recordClass II
Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
by A&H Focal Inc.
- 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.
- Published
- February 7, 2018
- Distribution
- NY and NJ through six retail stores name…
View recall →
FDA Recall
Terminated
Historical recordClass I
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
by International Laboratories, LLC
- Reason
- LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
by Fresenius Kabi USA, LLC
- Reason
- Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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