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

Recalls for July 2017

Recalling FirmClassProduct(s) Reason
Organic Herbal SupplyI11 productsMarketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
AstraZenecaIBrilantaPresence of Foreign Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Teva PharmaceuticalsIPaliperidone ER TabletsFailed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Bristol -Myers SquibbIEliquis TabletsLabeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.
Allergan Sales, LLCIIBlephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP)Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
American Pharmaceutical Ingredients LLCIIDoxycycline Hyclate USP, active pharmaceutical ingredientLabeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Apothecary By DesignIIProgesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mLCGMP Deviations: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
Xttrium Laboratories Inc.IIChlorhexidine GluconateCGMP Deviations
Phillips Co.II6 productsGMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Alvogen IncII3 productsLack of Assurance of Sterility
Fagron Compounding ServicesIISuccinylcholine ChlorideLack of Assurance of Sterility: voluntary recall initiated by the commercial supplier
GSK Consumer HealthcareIIParodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis ToothpastePresence of Foreign Substance: possibility of the presence of metal in the product
American Pharmaceutical Ingredients LLCIIMethocarbamol, USPCGMP Deviations: Lack of quality assurance at the API manufacturer  
Sigan Industries IncIICVS Health Baby Eczema Moisturizing CreamMicrobial Contamination of Non Sterile Products; out of specification Total Plate Count
Advanced Pharma IncII4 productsLack of Sterility Assurance
Baxter HealthcareII3 productsLack of Assurance of Sterility: Bags have the potential to leak.
SCA PharmaceuticalsII36 productsLack of assurance of sterility; product has the potential to leak.
Pharmedium Services LLCII13 productsLack of Assurance of Sterility; media fill failure at manufacturer
McKesson Packaging servicesIIIBuPROPion HCL Tablets, USP, 75 mgFailed Moisture Limits: Product tested out-of-specification for moisture content.
L. Perrigo CompanyIIIWalgreens Daytime and Nighttime Cold & FluLabeling: Label Mix-Up – This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.
Noven PharmaceuticalsIIIMinivelle (estradiol Transdermal System)Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Sanofi-AventisIIIGavisconSuperpotent Drug: high out-of-specification result for magnesium
G&W Laboratories, Inc.IIIG & W Clobetasol Propionate OintmentFailed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
Lantheus MI pharmaceuticals Inc.IIIFludeoxyglucose F 18 InjectionFailed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Pharmedium Services LLCIII7 productsLabeling: Incorrect or Missing Lot and/or Exp Date
Sandoz IncIIIAmitriptyline HCl TabletsCross Contamination with Other Product: Imipramine
Shionogi IncIII2 strengths, Mefenamic AcidFailed Dissolution Specifications: Low dissolution results were obtained during stability testing
Teva PharmaceuticalsIII2 strengths Buprenorphine and Naloxone Sublingual TabletsFailed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Valeant PharmaceuticalsIIIObagi-C Rx System C-Therapy Night Cream    Labeling: Incorrect or Missing Package Insert – Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
HospiraIIIArgatroban InjectionFailed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three-month time point
Lupin Pharmaceuticals IncIIIParoxetine ER TabletsFailed Dissolution Specifications: out of specification observed in dissolution testing at 3-month long term stability study.

Unclassified Recalls for July 2017

Recalling FirmProduct(s)Reason
Novo Nordisk announcement and FDA announcementInsulin cartridge holders in NovoPen EchoMay crack or break if exposed to certain chemical like certain cleaning agents.
GSKMENVEO Solution for Intramuscular injectionIntervention during the aseptic filling operation is not supported by validation data.
Apace Packaging LLCCyclobenzaprine tabletA small number of cartons containing Cyclobenzaprine HCl Tablets 5 mg UD Blister Cards may potentially be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters inside the carton are correctly labeled as Cyclobenzaprine HCl Tablet, USP 5 mg.
Guardian Pharmacy Services a compounding pharmacyIntravitreal (eye) injections of a drug containing triamcinolone (steroid) and moxifloxacin (anti-infective) compounded by Guardian Pharmacy Services in Dallas, Texas.This was a healthcare professional alert, not a recall.  It was based upon the receipt of adverse event reports regarding 43 patients.
ICU Medical Inc.0.9% Sodium Chloride Injection 1000mLConfirmed customer complaint of particulate matter identified as stainless steel within a single flexible container.  The affected product lot was manufactured in the U.S. by Hospira, a Pfizer company, on February 1, 2016 and was distributed nationwide to Hospira customers between April 14, 2016 and February 2, 2017
Cantrell Drug CompanyAll unexpired sterile drug products distributed to hospital and user level.Lack of sterility assurance
Rugby LaboratoriesDiocto Liquid and Diocto SyrupProduct is manufactured by PharmaTech, LLC due to a risk of product contamination with Burkholderia cepacia. FDA informed Rugby that it received several adverse event reports of B. cepacia infections in patients which may be linked to Diocto Liquid or Diocto Syrup manufactured by PharmaTech LLC
ImprimisRxCurcumin (a component of the spice turmeric) compounded with polyethylene glycol (PEG) 40 castor oilFDA issued warning to healthcare professionals regarding adverse events upon administration of infusion of curcumin compounded with PEG  40 castor oil. Further all unexpired products containing the ‘ungraded PEG 40 castor oil’ were recalled.   Additional information regarding the FDA Investigation and Compounding Risk Alerts may be found at the link in this row.

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
July 12, 2017PROSANA DISTRIBUCIONES SA DE CV Calle Oriente 225 97-1, Iztacalco, Col. AGRICOLA ORIENTAL, Mexico, Distrito Federal MEXICO  MEXICO
IMPORT ALERT 66-41, Detention Without Physical Examination of Unapproved New Drugs Promoted in the United States
July 12, 2017Cosmaprof Co Ltd 42, 44, 46, Soi Ramkhamhaeng 60/3, Huamark, Bang Kapi, Bangkok THAILAND  THAILAND
July 21, 2017Fragrance Productions Zi Pollot, Chartres, FRANCE  France
July 21, 2017PT. Surya Donasin Km. 8, Jalan Jendral Sudirman No 128, Cirebon, Jawa Barat INDONESIA  Indonesia
August 2, 2017H&R Global Incorporated Indianapolis USA Tampa, FL 33617 UNITED STATES  Tampa FL
July 24, 2017ADRET RETAIL PVT LTD 1 Gupta Lane, Kolkata, West Bengal INDIA  India
August 3, 2017Maharishi Ayurveda Products Pvt. Ltd. 17 & 18, Noida Special Economic Zone, Noida, Uttar Pradesh 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:

A corporate integrity agreement with Merck & Co. Inc. in Whitehouse Station NJ was closed on June 12, 2017

Consent Decree Agreement: 

  • An FDA press release reports that Isomeric Pharmacy Solutions of Salt Lake City Utah and two of the firm’s co-owners entered into a consent decree agreement with the courts. “According to the complaint for permanent injunction, Isomeric manufactured and distributed purportedly sterile drug products, including injectable and ophthalmic drugs that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act.” The firm is registered as an outsourcing facility. They conducted a nationwide recall of all products within expiry between October 4, 2016 and February 7, 2017 based on lack of sterility assurance.
  • The United States and Medistat RX LLC of Foley, Alabama, their owners and quality manager and pharmacist in charge entered into a consent decree agreement. The firm is registered as an outsourcing facility in 2014, and notified the FDA that they ceased operation in October 2015. The firm is prohibited from manufacturing, holding or distributing drugs until they comply with the FD&C Act and associated regulations and requirements. The FDA press release describes the holding of drugs under unsanitary conditions and the enforcement actions that the FDA took prior to this agreement.