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

Drug Recalls for September, 2017

Recalling FirmClassProduct(s) Reason
Andropharm LLCI2 products, recall of all lots within expiryMarketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Bestherbs Coffee LLCINew Kopi Jantan Tradisional Natural Herbs CoffeeMarketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Chiavna Saffron LLCISuper Panther 7K CapsulesMarketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildenafil and tadalafil
Tris PharmaIIMorphine Sulfate Oral Solution, 100 mg/ 5 mLDefective container: Oral solution leaking from container.
Morton Grove PharmaceuticalsIIAmoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mLPresence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product
Amphastar PharmaceuticalsIIKetorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vialsCrystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
ImprimisRx CA Inc (compounding / outsourcing facility)II4 productsIncorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Degasa Sa De Cv Calle Centenario 15 Col. DEPORTIVA JiutepecIIPovidone Iodine, USP Prep SolutionLabeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Medline IndustriesIIVitamin A&D OintmentLabeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.
Bella Pharmaceuticals IncII16 productsLack of assurance of sterility
ZydusIIParoxetine tablets USP, 30mg, 30-count bottles,Lot #: Z701133, Exp 03/19
Centurion Labs LLCII2 strengths of NinjacofMicrobial contamination of Non-sterile Products; potential B. cepacia contamination
Mid Valley PharmaceuticalII2 productsCGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
PharMedium Services LLCII2 strengths, Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only,Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
PfizerIIHYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, ILLack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process
PfizerIILevophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc.,Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process
Noven PharmaceuticalsII4 strengths Daytrana (methylphenidate transdermal system)Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
AmgenIIProcrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vialsPresence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Medisca IncIIAminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989-05, b) 1 kg jar (NDC 38779-0989-09), and 25 kg drum (NDC 38779-0989-07), Rx only,CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Pfizer IncIIIQuillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mLFailed Dissolution Specifications
Mckesson Packaging Services  IIIPropafenone Hydrochloride tablets, 150 mgFailed moisture limits: Out of specification for moisture content.
Lupin Pharmaceuticals  IIIFamotidine for Oral Suspension USPCGMP Deviations
Vista Pharm IncIIIHydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mLLabeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Aidarex Pharmaceuticals LLCIIIPhentermine, USP Capsules,Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30-month Room Temperature Retained Sample stability test
Ascend Laboratories LLCIIIAMLODIPINE BESYLATE TABLET, USP, 10 mg,PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.

Unclassified Recalls or Alerts for September 2017

Recalling FirmProduct(s)Reason
Genentech/RocheActivase®, 3 lotsLack of sterility assurance of Sterile WFI co-packaged with product.  Potentially cracked vials. Water manufactured by Hospira, a Pfizer company

FDA Import Alerts posted this month 

IMPORT ALERT 89-04, Detention Without Physical Examination of Devices from Firms that Have Not Met GMPs.
DateCompany and AddressCountry
Sept 27, 2017Alber GmbH Vor dem Weisen Stein 21, Albstadt, Baden-Wurttemberg GERMANYGERMANY
IMPORT ALERT 66-40, Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs
  Sept 14, 2017Hangzhou Facecare Cosmetics Co., Ltd. Dev. Area, Hangzhou Economic; 755 Nongken Road, Hangzhou, Zhejiang CHINA  CHINA
  Sept 14, 2017Shanghai Weierya Daily Chemicals Factory No. 1072 Dongsheng Lu, Shanghai, Shanghai CHINA  CHINA
Sept 28, 2017Delta Laboratories Pty Ltd 8 Warringah CL , Somersby, New South Wales AUSTRALIAAUSTRALIA
IMPORT ALERT 66-41, Detention Without Physical Examination of Unapproved New Drugs Promoted in the United States
Sept 13, 2017Drogueria Y Laboratorio Butter Pharma Division De Koret Sa D
  Sept 13, 2017laboratorio Butter Pharma Carretera Comalapa Km 12 1/2, San Marcos, EL SALVADOR  EL SALVADOR
Sept 19, 2017Turkuaz Medikal Kozmetik Ve No:34/3 Yakuplu Mahallesi Beysan, Istanbul, TURKEYTurkey
Sept 29, 2017LMZ INTERNATIONAL LTD NO 2 Changfeng Road Liuzhou Guangxi , Liuzhou, Guangxi CHINACHINA
IMPORT ALERT 99-32, detention without physical examination of products from firms refusing FDA foreign establishment inspection
  Sept 13, 2017Alex Industries Plot No 9109/4-5 Gidc Industrial Estate, Nr. Ion Exchange, Kanoria Chemical Road, Ankleshwar, Gujarat INDIA  INDIA
Sept 19, 2017Tianjin Zhongxin Pharmaceutical Group Corp., Ltd. Longshunrong Pharmaceutical Factory , NO. 21 10th Avenue, Teda , Tianjin, Tianjin CHINAChina
Sept 28, 2017Hubei Merryclin Pharmaceutical Co., Ltd. Yunmeng , 8 Heping Road; Economic Development Zone , Xiaogan, Hubei CHINACHINA
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 this week.

Consent Decree Agreement: 

  • An FDA press release announced Aegerion Pharmaceuticals pleads guilty and agrees to enter into a consent decree agreement. At issue is the firm’s failure to comply with the REMS program and labeling that lacked adequate directions for all of the drug’s intended uses.
  • Flawless Beauty (NJ), it’s co-owners and an affiliated company (RDG Imports LLC) entered into a consent decree agreement with the US. The firm has stopped selling its products and recalled some.  According to the FDA press release, According to the complaint for permanent injunction, which the U.S. Department of Justice filed on the FDA’s behalf, Flawless Beauty sold unapproved and improperly labeled (misbranded) drugs which present serious public health risks, particularly purportedly sterile injectable skin whitening drug products. Intravenous and intramuscular administration of these unapproved drugs, for which sterility cannot be assured, could result in serious health risks.”