FDA Issued 42 Product Recalls, Import Alerts, and Consent Decrees in December 2017

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.
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

Dec 21, 2017 Ming Fai Industrial (Shenzhen) Co LTD

Bainikeng, Pinghu, Ming Fai Industrial Estate, Shenzhen, Guangdong CHINA

Dec 27, 2017 Nox Bellcow Cosmetics Co. Ltd.

No. 50 Dongfu North Road, Nantou Town, Zhongshan City, Guangdong CHINA

Dec 27, 2017 Nowcos Co Ltd

53714 Segyo Dong , Pyeongtaek, KOREA, REPUBLIC OF (SOUTH)

Dec 27, 2017 Nowcos Co., Ltd

220 Sandan-gil, Jeonui-myeon, Sejong-si, KOREA, REPUBLIC OF (SOUTH)

Dec 27, 2017 Nowcos Co., Ltd

339-853 Jeon Ui Local Industrial Zo0sin, Yeon Gi-gun Chung Nam, KOREA, REPUBLIC OF (SOUTH)

Dec 27, 2017 Nowcos Co., Ltd.

37 Ayamok-gil , Sojeong-myeon , Sejong, KOREA, REPUBLIC OF (SOUTH)

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

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

Dec 5, 2017 IBEAUTY S.R.L.

Via Gaetano Donizetti, Brembate di Sopra, ITALY

Dec. 8, 2017 HYD LLC for Cancer Research and Drug Development

Furj Utca 2, Budapest Xii, Budapest HUNGARY

Dec. 13, 2017 Horphag Research Lts

Karaiskaki 38kanika Alexander Crt, Limassol, CYPRUS

Dec 14, 2017 Herbal Solution’s Health S.A. de C.V.

Calzada Insurgentes Poniente No. 322 , Col. CENTRO , Irapuato, Guanajuato MEXICO


NO. 59 Nanshannanlu, Rongcheng, Weihai, Shandong 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

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

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at sales@fdazilla.com.

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