Drug and pharmaceutical recalls
17729 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IITationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.
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.
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IILaroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche
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.
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IITatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan
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.
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IIRelumins Vitamin C Solvent ampules
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.
- 2018-02-14FDA-DrugFlawless Beauty LLCClass IIRelumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials
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.
- 2018-02-14FDA-DrugIntrathecal Compounding Specialist, LLCClass IIAll sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Lack of sterility assurance.
- 2018-02-14FDA-DrugIntrathecal Compounding Specialist, LLCClass IIAll sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Lack of sterility assurance.
- 2018-02-14FDA-DrugIntrathecal Compounding Specialist, LLCClass IIAll sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Lack of sterility assurance.
- 2018-02-14FDA-DrugIntrathecal Compounding Specialist, LLCClass IIAll sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Lack of sterility assurance.
- 2018-02-14FDA-DrugG & W Laboratories, Inc.Class IIICiclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
- 2018-02-07FDA-DrugBaxter Healthcare CorporationClass INexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
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
- 2018-02-07FDA-DrugA&H Focal Inc.Class IITiger King tablets, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IMACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class ILIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IDADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IPower V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IYANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IHU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IIMAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IISTREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IZhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IIYe Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IClalis capsules, 50mg, 6-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IGOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class ILANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IIHARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IGERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IGERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language
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.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IMiraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language
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.
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