FDA Issued 48 Product Recalls, Import Alerts, and Consent Decrees in July 2017

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

Recalls for July 2017

Recalling Firm Class Product(s)  Reason
Organic Herbal Supply I 11 products Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
AstraZeneca I Brilanta Presence 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 Pharmaceuticals I Paliperidone ER Tablets Failed 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 Squibb I Eliquis Tablets Labeling: 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, LLC II Blephamide (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 LLC II Doxycycline Hyclate USP, active pharmaceutical ingredient Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Apothecary By Design II Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL CGMP 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. II Chlorhexidine Gluconate CGMP Deviations
Phillips Co. II 6 products GMP 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 Inc II 3 products Lack of Assurance of Sterility
Fagron Compounding Services II Succinylcholine Chloride Lack of Assurance of Sterility: voluntary recall initiated by the commercial supplier
GSK Consumer Healthcare II Parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste Presence of Foreign Substance: possibility of the presence of metal in the product
American Pharmaceutical Ingredients LLC II Methocarbamol, USP CGMP Deviations: Lack of quality assurance at the API manufacturer

 

Sigan Industries Inc II CVS Health Baby Eczema Moisturizing Cream Microbial Contamination of Non Sterile Products; out of specification Total Plate Count
Advanced Pharma Inc II 4 products Lack of Sterility Assurance
Baxter Healthcare II 3 products Lack of Assurance of Sterility: Bags have the potential to leak.
SCA Pharmaceuticals II 36 products Lack of assurance of sterility; product has the potential to leak.
Pharmedium Services LLC II 13 products Lack of Assurance of Sterility; media fill failure at manufacturer
McKesson Packaging services III BuPROPion HCL Tablets, USP, 75 mg Failed Moisture Limits: Product tested out-of-specification for moisture content.
L. Perrigo Company III Walgreens Daytime and Nighttime Cold & Flu Labeling: 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 Pharmaceuticals III Minivelle (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-Aventis III Gaviscon Superpotent Drug: high out-of-specification result for magnesium
G&W Laboratories, Inc. III G & W Clobetasol Propionate Ointment Failed 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. III Fludeoxyglucose F 18 Injection Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Pharmedium Services LLC III 7 products Labeling: Incorrect or Missing Lot and/or Exp Date
Sandoz Inc III Amitriptyline HCl Tablets Cross Contamination with Other Product: Imipramine
Shionogi Inc III 2 strengths, Mefenamic Acid Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
Teva Pharmaceuticals III 2 strengths Buprenorphine and Naloxone Sublingual Tablets Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Valeant Pharmaceuticals III Obagi-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.
Hospira III Argatroban Injection Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three-month time point
Lupin Pharmaceuticals Inc III Paroxetine ER Tablets Failed Dissolution Specifications: out of specification observed in dissolution testing at 3-month long term stability study.

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Unclassified Recalls for July 2017

Recalling Firm Product(s) Reason
Novo Nordisk announcement and

FDA announcement

Insulin cartridge holders in NovoPen Echo May crack or break if exposed to certain chemical like certain cleaning agents.
GSK MENVEO Solution for Intramuscular injection Intervention during the aseptic filling operation is not supported by validation data.
Apace Packaging LLC Cyclobenzaprine tablet A 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 pharmacy Intravitreal (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 1000mL Confirmed 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 Company All unexpired sterile drug products distributed to hospital and user level. Lack of sterility assurance
Rugby Laboratories Diocto Liquid and Diocto Syrup Product 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
ImprimisRx Curcumin (a component of the spice turmeric) compounded with polyethylene glycol (PEG) 40 castor oil FDA 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
Date Company and Address Country
NONE
IMPORT ALERT 66-40, Detention Without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs
July 12, 2017 PROSANA 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, 2017 Cosmaprof Co Ltd

42, 44, 46, Soi Ramkhamhaeng 60/3, Huamark, Bang Kapi, Bangkok THAILAND

 

THAILAND

July 21, 2017 Fragrance Productions

Zi Pollot, Chartres, FRANCE

 

France

July 21, 2017 PT. Surya Donasin

Km. 8, Jalan Jendral Sudirman No 128, Cirebon, Jawa Barat INDONESIA

 

Indonesia

July 21, 2017 IOTTIE KOREA

WANGSIMNI-RO 58 SEONGDO, NG-GU, SEOUL, KOREA, REPUBLIC OF (SOUTH)

 

South Korea

August 2, 2017 H&R Global Incorporated Indianapolis USA

Tampa, FL 33617 UNITED STATES

 

Tampa FL

July 24, 2017 ADRET RETAIL PVT LTD

1 Gupta Lane, Kolkata, West Bengal INDIA

 

India

August 3, 2017 Maharishi Ayurveda Products Pvt. Ltd.

17 & 18, Noida Special Economic Zone, Noida, Uttar Pradesh INDIA

 

India

August 3, 2017 WIPRO ENTERPRISES LTD

SURYA LABORATRIES PLOT, BELWADI INDL AREA, MYSORE, 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: 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.

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