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

Recalls for August, 2017

Recalling FirmClassProduct(s)Reason
C.O. TruxtonI6 productsLabeling: Labeled mix up, potentially mislabeled
Brian P. RichardsonICaverFlo Natural Herbal CoffeeMarketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Genetic Edge CompoundsIGEC LX Laxoplex 60 capsules Dietary SupplementMarketed 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 LimitedIMibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) TabletsContraceptive 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 FormulationsIBiotech Underground Tri-Ton Hardcore Formula capsulesMarketed 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 FormulationsI2 products, all lots within expiryMarketed Without an Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
The Harvard Drug GroupII5 productsMicrobial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Bayer HealthCare PharmaceuticalsII3 strengths Alka-Seltzer OriginalDefective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Hospira a Pfizer CompanyII4 injectable productsLack of Sterility Assurance
Time-Cap Laboratories, Inc.IIIbuprofen TabletsPresence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg
Apace KY LLCII2 product recallsLabeling; 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 IncIIOxygen, refrigerated Liquid USPGMP Deviations: The firm does not include an SOP for testing for out of specifications.
Cantrell Drug CompanyII17 productsLack of sterility assurance
X-Gen PharmaceuticalIINystatin Topical PowderPresence of Foreign Substance: potential presence of plastic particles.
HospiraII3 strengths, Hydromorphone Hydrochloride Injection, USPPresence of Particulate Matter: Silicone oil
VistaPharm, Inc.II2 strengths Lactulose Solution, USPMicrobial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Zydus Pharmaceuticals USA IncII3 strengths Divalproex Sodium Delayed Release Tablets, USPFailed Dissolution Specifications
Precision Dose IncIICarbamazepine Oral SuspensionLabeling Error: Label mix-up. Products’ unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC
Fusion IV PharmaceuticalsIITestosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los AngelesCGMP Deviations
Vi-Jon Inc.IIMagnesium Citrate Oral SolutionMicrobial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis
TevaIIFamotidine TabletsFailed Tablet/Capsule Specification; out of specification for tablet weight
PD-Rx PhrmaceuticalsIIFamotidine TabletsFailed Tablet/Capsule Specification; out of specification for tablet weight
Global Marketing EnterprisesIICaffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeineMarketed 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.II0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible ContainerPresence of Particulate Matter; stainless steel
AmgenIIProcrit Epoetin Alfa 40,000 units/mL single use vialPresence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials
TevaIIIAlbuterol Sulfate Inhalation SolutionFailed Impurities/Degradation Specifications: high out of specification results for related compound D
Dr. Reddy’s Laboatories, Inc.IIIPravastatin Sodium Tablets, USPFailed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220
Teva PharmaceuticalsIIIGlipizide Extended-Release TabletsFailed Moisture Limits: out of specification test results for water content obtained during stability testing  
Akorn IncIII2 kit types, Halyard 24-Hour Oral Care KitCrystallization with subpotent out of specification assay results for chlorhexidine.
AVKARE Inc.IIIVoriconazole Tablets, 200 mg, 20-count cartonsFailed impurities/degradation specifications: Out of specification for a related compound C.
Linde Eckstein Gmbh + CoIIIFourteen productssubpotent
KVK-Tech IncIIIPhentermine HCL Capsules, USP 15 mgFailed 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 FirmProduct(s)Reason
Teva PharmaceuticalsIIIFailed 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 productsOn 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 againLiquid 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 LaboratoriesPravastatin Sodium tabletsThe product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets.
Amneal PharmaceuticalsLorazepam oral concentrateIn 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 IncRecalling 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 PharmaceuticalDoctor Manzanilla Cough & Cold AND Doctor Manzanilla Allergy & Decongestant Relief SyrupPotential contamination with Burkholderia cepacian
HospiraVancomycin InjectionConfirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial.
HospiraHydromorphone 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.
PharMEDiumAll 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, 2017Laboratory 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 issuesNOTICE 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 productsLack of sterility assurance
Centurion LabsNinjacof and Ninjakof ACenturion 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.
DateCompany and AddressCountry
IMPORT ALERT 66-40, Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs
August 11, 2017Changzhou Anyuan Import & Export Fuchen Garden Suite, 1-403; Xinbei District, Changzhou, Jiangsu CHINACHINA
August 11, 2017Yicheng Chemical Corp. Fuchen Garden Suite, 1-402; Xinbei District, Changzhou, Jiangsu CHINACHINA
August 23, 2017Amaros Co., Ltd Jungwon-gu, 560 Dunchon-daero, Seongnam-si, KOREA, REPUBLIC OF (SOUTH)South Korea
  August 23, 2017Seindni Co., Ltd. Seongbuk-gu, 610-304 16, Gireum-ro, Seoul, KOREA, REPUBLIC OF (SOUTH)  South Korea
Aug 25, 2017Mahendra 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, 2017Israel Post Co 217, Jaffa Ro, Jerusalem, ISRAEL  ISRAEL
August 4, 2017Royal Sea Kehilat Lodge 18 , Tel Aviv, ISRAEL  ISRAEL
  August 9, 2017So Young Plus Pusat Perdagangan Bukit Serdang Jalan BS 14/1 , Suite #111, C-G-23 , Seri Kembangan, Selangor Darul Ehsan MALAYSIA  MALAYSIA
  August 9, 2017Syarikat Wen Ken Drug Sdn Bhd Jalan a, Johor Bahru, Johor MALAYSIA  MALAYSIA
August 11, 2017Keasri Ayurvedic Pharmacy Abrama, VIA Vedchha , Gujarat, INDIA  India
  August 11, 2017Cafe Del Pacifico Sa De Cv Blvd Enrique Mazon Lopez 626 , Hermosillohermosillo, MEXICO  MEXICO
  August 14, 2017SG (CHINA) No. 26 Jianguomen Eni Da Jie, 5th Floor, Beijing News Plaza, Beijing, Tianjin, CHINA  CHINA
August 16, 2017NuEra Nutraceutical Inc 12031 No. 5 Rd, Richmond, British Columbia CANADA  CANADA
  August 16, 2017INKA FOREST EXPORT Asoc San Francisco, Lima, PERU  PERU
  August 21, 2017SHENZHEN TWOSUCCESS ELECTRONICS Room 508, Ruida Science, Shenzhen City, CHINA  China
  August 21, 2017Shenzhen Keshangda Electronics Technology Co., Ltd. 6 Bld, Shantang Industrial Park Paibang Village, Henggang Town Longgang Dist., Shenzhen, Guangdong CHINA  China
  Aug 25, 2017NEW LIFE NATURAL VEGETATION CELL Lucaya Shopping Cent 14, Freeport City, BAHAMAS  Bahamas
  Aug 25, 2017Biocell SARL 48 avenue Jeanne, Soisy sous Montmorency, Val d’Oise FRANCE  France
  Aug 25, 2017UNIQUE 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
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: