Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month!
Drug Recalls for December, 2017
| Recalling Firm | Class | Product(s) | Reason |
| EZ Weight Loss TX LLC | I | 2 LaBri’s Body Health products | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: products found to be tainted with sibutramine making these unapproved drugs |
| The Ampt Life LLC | I | Natural Herbal Coffee AMPT | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall |
| Amneal Pharmaceuticals | I | Lorazepam Oral Concentrate | Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing |
| Pfizer | I | Vancomycin HCl | Presence of Particulate Matter: glass particulate found in vial |
| International Laboratories Inc | I | Pravastatin Sodium Tablets | Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg |
| Gadget Island Inc. | I | 3 different products | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil |
| New Reliance Trading Inc | II | No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, | Marketed Without an Approved NDA/ANDA |
| Mayne Pharma Inc | II | Liothyronine Sodium Tablets, USP | Failed Dissolution Specifications |
| Teva Pharmaceuticals USA | II | Clozapine Tablets USP | CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity |
| Lupin Pharmaceuticals Inc | II | Duloxetine Delayed-Release Capsules USP | Failed Dissolution Specification |
| Zydus Pharmaceuticals USA Inc | II | Paroxetine Tablets USP | Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets |
| Sun Pharmaceuticals | II | Riomet (metformin hydrochloride) Oral Solution Cherry Flavored | Microbial Contamination of Non-Sterile Products |
| Teva Pharmaceuticals | III | PenicillinV Potassium for Oral Solution | Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities |
| Advanced Pharma Inc. | II | 7 Nitroglycerin sterile injectable products | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system |
| B. Braun Medical | II | 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container | Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap |
| L. Perrigo Co. | II | Maximum Strength Zephrex-D, Pseudoephedrine HCl | Microbial Contamination of Non-Sterile Products |
| Teva Pharmaceuticals | II | Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, | Labeling: Incorrect Instructions. “TABLETS IN WEEK 4 ARE INACTIVE” printed on the blister foil and package insert, however, all tablets are active |
| Premier Pharmacy Labs Inc | II | Neostigmine Methylsulfate | Stability Date Doesn’t Support Expiry: labeling error indicating a beyond use date that exceeds current stability data |
| Elite Laboratories Inc | III | Isradapine Capsules | Failed Impurities/Degradation Specifications |
| Claris | III | Ciprofloxacin in Dextrose Injection | Superpotent |
| Renaissance Lakewood LLC | III | Fluconazole Injection, USP | Superpotent |
| Osmotica Pharmaceutical Corp | III | 2 strengths, Methylphenidate Hydrochloride Extended-release Tablets | Subpotent Drug |
Unclassified Recalls or Alerts
| Firm | Product(s) | Reason |
| Simple Diagnostics Inc product is made by Foshan Flying Medical of China | Alcohol pads | Lack of sterility assurance and other quality issues |
| Sanofi Genzyme | Sinvisc-One | Lot tested positive for microbial contamination |
| AuroMedics Pharma LLC | Pantoprazole Sodium for Injection | Presence of Glass Particles in the Vial |
| Auromedics Pharma LLC | Linezolid Injection 600mg/300mL | The product was found to contain white particulate matter that has been identified as mold |
FDA Import Alerts posted this month
| IMPORT ALERT 89-04, Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements. | ||
| NONE THIS MONTH | ||
| IMPORT ALERT 66-40, Detention Without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs | ||
| Dec 13, 2017 | Malladi Drugs & Pharmaceuticals Ltd. Plot 67, 68, Sipcot Industrial Complex, Vellore, Ranipet, Tamil Nadu INDIA | INDIA |
| Dec 21, 2017 | Ming Fai Industrial (Shenzhen) Co LTD Bainikeng, Pinghu, Ming Fai Industrial Estate, Shenzhen, Guangdong CHINA | CHINA |
| Dec 27, 2017 | Nox Bellcow Cosmetics Co. Ltd. No. 50 Dongfu North Road, Nantou Town, Zhongshan City, Guangdong CHINA | CHINA |
| Dec 27, 2017 | Nowcos Co Ltd 53714 Segyo Dong , Pyeongtaek, KOREA, REPUBLIC OF (SOUTH) | SOUTH KOREA |
| Dec 27, 2017 | Nowcos Co., Ltd 220 Sandan-gil, Jeonui-myeon, Sejong-si, KOREA, REPUBLIC OF (SOUTH) | SOUTH KOREA |
| Dec 27, 2017 | Nowcos Co., Ltd 339-853 Jeon Ui Local Industrial Zo0sin, Yeon Gi-gun Chung Nam, KOREA, REPUBLIC OF (SOUTH) | SOUTH KOREA |
| Dec 27, 2017 | Nowcos Co., Ltd. 37 Ayamok-gil , Sojeong-myeon , Sejong, KOREA, REPUBLIC OF (SOUTH) | SOUTH KOREA |
| Dec 27, 2017 | Nowcos Nots 371-17 Byc Highway, Seoul, KOREA, REPUBLIC OF (SOUTH) | South Korea |
| Dec 28, 2017 | Zhejiang Ludao Technology Co., Ltd. No. 5 Industry Road, Hairun Street, Taizhou, CHINA | CHINA |
| IMPORT ALERT 66-41, Detention Without Physical Examination of Unapproved New Drugs Promoted in the United States | ||
| Dec 5, 2017 | Gansu meheco import & export co., ltd 360 Jiayuguan, Lanzhou, Gansu CHINA | CHINA |
| Dec 5, 2017 | IBEAUTY S.R.L. Via Gaetano Donizetti, Brembate di Sopra, ITALY | ITALY |
| Dec. 8, 2017 | HYD LLC for Cancer Research and Drug Development Furj Utca 2, Budapest Xii, Budapest HUNGARY | Hungary |
| Dec. 13, 2017 | Horphag Research Lts Karaiskaki 38kanika Alexander Crt, Limassol, CYPRUS | CYPRUS |
| Dec 14, 2017 | Herbal Solution’s Health S.A. de C.V. Calzada Insurgentes Poniente No. 322 , Col. CENTRO , Irapuato, Guanajuato MEXICO | MEXICO |
| Dec 8, 2017 | SHANDONG HONGDA GROUP NO. 59 Nanshannanlu, Rongcheng, Weihai, Shandong CHINA | China |
| IMPORT ALERT 99-32, detention without physical examination of products from firms refusing FDA foreign establishment inspection | ||
| Dec 28, 2017 | Yunnan Baiyao Group Co., Ltd. NO. 3686 Yunnan Baiyao Street, Chenggong District, Kunming, Yunnan CHINA | CHINA |
| IMPORT ALERT 99-34, Detention Without Physical Examination of Drugs or Medical Devices for Firms without a Valid Drug or Medical Device Registration | ||
| NONE THIS MONTH | ||
| IMPORT ALERT 89-16 Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspections | ||
| NONE THIS MONTH | ||
| IMPORT ALERT 66-57: Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Promoted to Individuals in the U. S | ||
| NONE THIS MONTH |
Corporate Integrity Agreements: None
Consent Decree Agreement: None