FDA Issued 66 Product Recalls, Import Alerts, and Consent Decrees in August 2017

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month!

Recalls for August, 2017

Recalling Firm Class Product(s) Reason
C.O. Truxton I 6 products Labeling: Labeled mix up, potentially mislabeled
Brian P. Richardson I CaverFlo Natural Herbal Coffee Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Genetic Edge Compounds I GEC LX Laxoplex 60 capsules Dietary Supplement Marketed Without an Approved NDA/ANDA: Tainted Product Marketed as a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.
Lupin Limited I Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Dynamic Technical Formulations I Biotech Underground Tri-Ton Hardcore Formula capsules Marketed Without an Approved NDA/ANDA: Tainted Product Marketed as a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
Hardcore Formulations I 2 products, all lots within expiry Marketed Without an Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
The Harvard Drug Group II 5 products Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Bayer HealthCare Pharmaceuticals II 3 strengths Alka-Seltzer Original Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Hospira a Pfizer Company II 4 injectable products Lack of Sterility Assurance
Time-Cap Laboratories, Inc. II Ibuprofen Tablets Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg
Apace KY LLC II 2 product recalls Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
At Home Medical Inc II Oxygen, refrigerated Liquid USP GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Cantrell Drug Company II 17 products Lack of sterility assurance
X-Gen Pharmaceutical II Nystatin Topical Powder Presence of Foreign Substance: potential presence of plastic particles.
Hospira II 3 strengths, Hydromorphone Hydrochloride Injection, USP Presence of Particulate Matter: Silicone oil
VistaPharm, Inc. II 2 strengths Lactulose Solution, USP Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Zydus Pharmaceuticals USA Inc II 3 strengths Divalproex Sodium Delayed Release Tablets, USP Failed Dissolution Specifications
Precision Dose Inc II Carbamazepine Oral Suspension Labeling Error: Label mix-up. Products’ unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC
Fusion IV Pharmaceuticals II Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles CGMP Deviations
Vi-Jon Inc. II Magnesium Citrate Oral Solution Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis
Teva II Famotidine Tablets Failed Tablet/Capsule Specification; out of specification for tablet weight
PD-Rx Phrmaceuticals II Famotidine Tablets Failed Tablet/Capsule Specification; out of specification for tablet weight
Global Marketing Enterprises II Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.
ICU Medical Inc. II 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container Presence of Particulate Matter; stainless steel
Amgen II Procrit Epoetin Alfa 40,000 units/mL single use vial Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials
Teva III Albuterol Sulfate Inhalation Solution Failed Impurities/Degradation Specifications: high out of specification results for related compound D
Dr. Reddy’s Laboatories, Inc. III Pravastatin Sodium Tablets, USP Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220
Teva Pharmaceuticals III Glipizide Extended-Release Tablets Failed Moisture Limits: out of specification test results for water content obtained during stability testing

 

Akorn Inc III 2 kit types, Halyard 24-Hour Oral Care Kit Crystallization with subpotent out of specification assay results for chlorhexidine.
AVKARE Inc. III Voriconazole Tablets, 200 mg, 20-count cartons Failed impurities/degradation specifications: Out of specification for a related compound C.
Linde Eckstein Gmbh + Co III Fourteen products subpotent
KVK-Tech Inc III Phentermine HCL Capsules, USP 15 mg Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30-month Room Temperature Retained Sample stability test.

Unclassified Recalls or Alerts for the Month of August

Recalling Firm Product(s) Reason
Teva Pharmaceuticals III Failed Moisture Limits: out of specification test results for water content obtained during stability testing
Vital Rx Inc, dba Atlantic Pharmacy and Compounding (a compounding pharmacy) All sterile products On July 31, 2017, FDA recommended that Atlantic Pharmacy cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile. The company has not yet initiated a recall.  Therefore, FDA is alerting health care professionals and patients to dispose of and not use drug products.
PharmaTech again Liquid drug products distributed by Rugby and others. The press release has specifics. FDA avdvisory — Not to Use due to Burkholderia cepacia contamination and the potential for severe patient infection
International Laboratories Pravastatin Sodium tablets The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets.
Amneal Pharmaceuticals Lorazepam oral concentrate In a few instances, the dropper is printed with the dose markings in reverse number order, has no dose markings or has dose markings that are shifted.
Vital Rx Inc Recalling all lots of all compounded injectable prescription medications to the consumer level. The compounded injectable prescription medications have been found to lack sterility assurance.
Mid-Valley Pharmaceutical Doctor Manzanilla Cough & Cold AND Doctor Manzanilla Allergy & Decongestant Relief Syrup Potential contamination with Burkholderia cepacian
Hospira Vancomycin Injection Confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial.
Hospira Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and Levophed® (Norepinephrine Bitartrate Injection, USP) Potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
PharMEDium All unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 Laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered.
Foshan Flying Medical Products

Warning Letter issued August 1, 2017; firm placed on import alert on May 23, 2017 for failure to meet GMPs.

Alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues NOTICE TO HEALTHCARE PROFESSIONALS, firm refuses to conduct a recall.  Products lack sterility assurance and inspection revealed other quality issues.
Bella Pharmaceuticals (compounding pharmacy) All lots of unexpired sterile drug products Lack of sterility assurance
Centurion Labs Ninjacof and Ninjakof A Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Partech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia.

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FDA Import Alerts

IMPORT ALERT 89-04, Detention Without Physical Examination of Devices from Firms that Have Not Met GMPs.
Date Company and Address Country
NONE
IMPORT ALERT 66-40, Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs
August 11, 2017 Changzhou Anyuan Import & Export

Fuchen Garden Suite, 1-403; Xinbei District, Changzhou, Jiangsu CHINA

CHINA
August 11, 2017 Yicheng Chemical Corp.

Fuchen Garden Suite, 1-402; Xinbei District, Changzhou, Jiangsu CHINA

CHINA
August 23, 2017 Amaros Co., Ltd

Jungwon-gu, 560 Dunchon-daero, Seongnam-si, KOREA, REPUBLIC OF (SOUTH)

South Korea
 

August 23, 2017

Seindni Co., Ltd.

Seongbuk-gu, 610-304 16, Gireum-ro, Seoul, KOREA, REPUBLIC OF (SOUTH)

 

South Korea

Aug 25, 2017 Mahendra Chemicals

B – 1 217 218 2 G I D C Estate, Ahmedabad, Gujarat INDIA

 

INDIA

IMPORT ALERT 66-41, Detention Without Physical Examination of Unapproved New Drugs Promoted in the United States
 

August 4, 2017

Israel Post Co

217, Jaffa Ro, Jerusalem, ISRAEL

 

ISRAEL

August 4, 2017 Royal Sea

Kehilat Lodge 18 , Tel Aviv, ISRAEL

 

ISRAEL

 

August 9, 2017

So Young Plus

Pusat Perdagangan Bukit Serdang Jalan BS 14/1 , Suite #111, C-G-23 , Seri Kembangan, Selangor Darul Ehsan MALAYSIA

 

MALAYSIA

 

August 9, 2017

Syarikat Wen Ken Drug Sdn Bhd

Jalan a, Johor Bahru, Johor MALAYSIA

 

MALAYSIA

August 11, 2017 Keasri Ayurvedic Pharmacy

Abrama, VIA Vedchha , Gujarat, INDIA

 

India

 

August 11, 2017

Cafe Del Pacifico Sa De Cv

Blvd Enrique Mazon Lopez 626 , Hermosillohermosillo, MEXICO

 

MEXICO

August 14, 2017 RIGHTEOUS DRAGON MANAGEMENT GROU

7F, KOWLOON BLDG, 555 N, HONG KONG, CHINA

 

CHINA

 

August 14, 2017

SG (CHINA)

No. 26 Jianguomen Eni Da Jie, 5th Floor, Beijing News Plaza, Beijing, Tianjin, CHINA

 

CHINA

August 16, 2017 NuEra Nutraceutical Inc

12031 No. 5 Rd, Richmond, British Columbia CANADA

 

CANADA

 

August 16, 2017

INKA FOREST EXPORT

Asoc San Francisco, Lima, PERU

 

PERU

 

August 21, 2017

SHENZHEN TWOSUCCESS ELECTRONICS

Room 508, Ruida Science, Shenzhen City, CHINA

 

China

 

August 21, 2017

Shenzhen Keshangda Electronics Technology Co., Ltd.

6 Bld, Shantang Industrial Park Paibang Village, Henggang Town Longgang Dist., Shenzhen, Guangdong CHINA

 

China

 

Aug 25, 2017

NEW LIFE NATURAL VEGETATION CELL

Lucaya Shopping Cent 14, Freeport City, BAHAMAS

 

Bahamas

 

Aug 25, 2017

Biocell SARL

48 avenue Jeanne, Soisy sous Montmorency, Val d’Oise FRANCE

 

France

 

Aug 25, 2017

UNIQUE FRAGRANCES

Plot No, 21 Road No 1, New Delhi, Delhi INDIA

 

India

IMPORT ALERT 99-32, Detention without physical examination of products from firms refusing FDA foreign establishment inspection
NONE
IMPORT ALERT 99-34, Detention Without Physical Examination of Drugs or Medical Devices for Firms without a Valid Drug or Medical Device Registration
NONE
IMPORT ALERT 89-16 Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspections
NONE
IMPORT ALERT 66-57:  Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Promoted to Individuals in the U. S
NONE

Corporate Integrity Agreements:

Consent Decree Agreement:  None this month

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