February 14, 2018DrugsFDA
Flawless Beauty LLC recalls Relumins Vitamin C Solvent ampules
Hazard: Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
February 14, 2018DrugsFDA
Flawless Beauty LLC recalls Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials
Hazard: Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
February 14, 2018DrugsFDA
Intrathecal Compounding Specialist, LLC recalls All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between
Hazard: Lack of sterility assurance.
February 14, 2018DrugsFDA
Intrathecal Compounding Specialist, LLC recalls All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between
Hazard: Lack of sterility assurance.
February 14, 2018DrugsFDA
Intrathecal Compounding Specialist, LLC recalls All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between Octobe
Hazard: Lack of sterility assurance.
February 14, 2018DrugsFDA
Intrathecal Compounding Specialist, LLC recalls All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between Oc
Hazard: Lack of sterility assurance.
February 14, 2018DrugsFDA
G & W Laboratories, Inc. recalls Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and
Hazard: Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
February 7, 2018DrugsFDA
Baxter Healthcare Corporation recalls Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation
Hazard: Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
February 7, 2018DrugsFDA
A&H Focal Inc. recalls Tiger King tablets, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls Indian God Lotion Spray Bottle, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
A&H Focal Inc. recalls Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
Hazard: 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.
February 7, 2018DrugsFDA
International Laboratories, LLC recalls Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersbur
Hazard: LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.