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 FirmClassProduct(s) Reason
EZ Weight Loss TX LLCI2 LaBri’s Body Health productsMarketed 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 LLCINatural Herbal Coffee AMPTMarketed 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 PharmaceuticalsILorazepam Oral ConcentrateDefective Delivery System: the dropper measurement markings may be reversed, shifted or missing
PfizerIVancomycin HClPresence of Particulate Matter: glass particulate found in vial
International Laboratories IncIPravastatin Sodium TabletsLabeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg
Gadget Island Inc.I3 different productsMarketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil
New Reliance Trading IncIINo.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala,Marketed Without an Approved NDA/ANDA
Mayne Pharma IncIILiothyronine Sodium Tablets, USPFailed Dissolution Specifications
Teva Pharmaceuticals USAIIClozapine Tablets USPCGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity
Lupin Pharmaceuticals IncIIDuloxetine Delayed-Release Capsules USPFailed Dissolution Specification
Zydus Pharmaceuticals USA IncIIParoxetine Tablets USPPresence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Sun PharmaceuticalsIIRiomet (metformin hydrochloride) Oral Solution Cherry FlavoredMicrobial Contamination of Non-Sterile Products
Teva PharmaceuticalsIIIPenicillinV Potassium for Oral SolutionFailed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities
Advanced Pharma Inc.II7 Nitroglycerin sterile injectable productsStability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system
B. Braun MedicalII0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation ContainerPresence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
L. Perrigo Co.IIMaximum Strength Zephrex-D, Pseudoephedrine HClMicrobial Contamination of Non-Sterile Products
Teva PharmaceuticalsIIAmethyst (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 IncIINeostigmine MethylsulfateStability Date Doesn’t Support Expiry: labeling error indicating a beyond use date that exceeds current stability data
Elite Laboratories IncIIIIsradapine CapsulesFailed Impurities/Degradation Specifications
ClarisIIICiprofloxacin in Dextrose InjectionSuperpotent
Renaissance Lakewood LLCIIIFluconazole Injection, USPSuperpotent
Osmotica Pharmaceutical CorpIII2 strengths, Methylphenidate Hydrochloride Extended-release TabletsSubpotent Drug

 Unclassified Recalls or Alerts

Simple Diagnostics Inc product is made by Foshan Flying Medical of ChinaAlcohol padsLack of sterility assurance and other quality issues
Sanofi GenzymeSinvisc-OneLot tested positive for microbial contamination
AuroMedics Pharma LLCPantoprazole Sodium for InjectionPresence of Glass Particles in the Vial
Auromedics Pharma LLCLinezolid Injection 600mg/300mLThe 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.
IMPORT ALERT 66-40, Detention Without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs
Dec 13, 2017Malladi Drugs & Pharmaceuticals Ltd. Plot 67, 68, Sipcot Industrial Complex, Vellore, Ranipet, Tamil Nadu INDIAINDIA
Dec 21, 2017Ming Fai Industrial (Shenzhen) Co LTD Bainikeng, Pinghu, Ming Fai Industrial Estate, Shenzhen, Guangdong CHINACHINA
Dec 27, 2017Nox Bellcow Cosmetics Co. Ltd. No. 50 Dongfu North Road, Nantou Town, Zhongshan City, Guangdong CHINACHINA
Dec 27, 2017Nowcos Co Ltd 53714 Segyo Dong , Pyeongtaek, KOREA, REPUBLIC OF (SOUTH)SOUTH KOREA
Dec 27, 2017Nowcos Co., Ltd 220 Sandan-gil, Jeonui-myeon, Sejong-si, KOREA, REPUBLIC OF (SOUTH)SOUTH KOREA
Dec 27, 2017Nowcos Co., Ltd 339-853 Jeon Ui Local Industrial Zo0sin, Yeon Gi-gun Chung Nam, KOREA, REPUBLIC OF (SOUTH)SOUTH KOREA
Dec 27, 2017Nowcos Co., Ltd. 37 Ayamok-gil , Sojeong-myeon , Sejong, KOREA, REPUBLIC OF (SOUTH)SOUTH KOREA
Dec 27, 2017Nowcos Nots 371-17 Byc Highway, Seoul, KOREA, REPUBLIC OF (SOUTH)South Korea
Dec 28, 2017Zhejiang Ludao Technology Co., Ltd. No. 5 Industry Road, Hairun Street, Taizhou, CHINACHINA
IMPORT ALERT 66-41, Detention Without Physical Examination of Unapproved New Drugs Promoted in the United States
Dec 5, 2017Gansu meheco import & export co., ltd 360 Jiayuguan, Lanzhou, Gansu CHINACHINA
Dec 5, 2017IBEAUTY S.R.L. Via Gaetano Donizetti, Brembate di Sopra, ITALYITALY
Dec. 8, 2017HYD LLC for Cancer Research and Drug Development Furj Utca 2, Budapest Xii, Budapest HUNGARYHungary
Dec. 13, 2017Horphag Research Lts Karaiskaki 38kanika Alexander Crt, Limassol, CYPRUSCYPRUS
Dec 14, 2017Herbal Solution’s Health S.A. de C.V. Calzada Insurgentes Poniente No. 322 , Col. CENTRO , Irapuato, Guanajuato MEXICOMEXICO
Dec 8, 2017SHANDONG HONGDA GROUP NO. 59 Nanshannanlu, Rongcheng, Weihai, Shandong CHINAChina
IMPORT ALERT 99-32, detention without physical examination of products from firms refusing FDA foreign establishment inspection
Dec 28, 2017Yunnan Baiyao Group Co., Ltd. NO. 3686 Yunnan Baiyao Street, Chenggong District, Kunming, Yunnan CHINACHINA
IMPORT ALERT 99-34, Detention Without Physical Examination of Drugs or Medical Devices for Firms without a Valid Drug or Medical Device Registration
IMPORT ALERT 89-16 Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspections
IMPORT ALERT 66-57:  Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Promoted to Individuals in the U. S

Corporate Integrity Agreements:  None

Consent Decree Agreement: None