FDA Issued 36 Product Recalls, Import Alerts, and Consent Decrees in September 2017

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 Firm	Class	Product(s)	Reason
Andropharm LLC	I	2 products, recall of all lots within expiry	Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Bestherbs Coffee LLC	I	New Kopi Jantan Tradisional Natural Herbs Coffee	Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Chiavna Saffron LLC	I	Super Panther 7K Capsules	Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildenafil and tadalafil
Tris Pharma	II	Morphine Sulfate Oral Solution, 100 mg/ 5 mL	Defective container: Oral solution leaking from container.
Morton Grove Pharmaceuticals	II	Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL	Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product
Amphastar Pharmaceuticals	II	Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials	Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
ImprimisRx CA Inc (compounding / outsourcing facility)	II	4 products	Incorrect/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 Jiutepec	II	Povidone Iodine, USP Prep Solution	Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Medline Industries	II	Vitamin A&D Ointment	Labeling 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 Inc	II	16 products	Lack of assurance of sterility
Zydus	II	Paroxetine tablets USP, 30mg, 30-count bottles,	Lot #: Z701133, Exp 03/19
Centurion Labs LLC	II	2 strengths of Ninjacof	Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Mid Valley Pharmaceutical	II	2 products	CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
PharMedium Services LLC	II	2 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.
Pfizer	II	HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL	Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process
Pfizer	II	Levophed (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 Pharmaceuticals	II	4 strengths Daytrana (methylphenidate transdermal system)	Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Amgen	II	Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials	Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Medisca Inc	II	Aminocaproic 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 Inc	III	Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL	Failed Dissolution Specifications
Mckesson Packaging Services	III	Propafenone Hydrochloride tablets, 150 mg	Failed moisture limits: Out of specification for moisture content.
Lupin Pharmaceuticals	III	Famotidine for Oral Suspension USP	CGMP Deviations
Vista Pharm Inc	III	Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL	Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Aidarex Pharmaceuticals LLC	III	Phentermine, 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 LLC	III	AMLODIPINE 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 Firm	Product(s)	Reason
Genentech/Roche	Activase®, 3 lots	Lack 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.
Date	Company and Address	Country
Sept 27, 2017	Alber GmbH Vor dem Weisen Stein 21, Albstadt, Baden-Wurttemberg GERMANY	GERMANY
IMPORT ALERT 66-40, Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs
Sept 14, 2017	Hangzhou Facecare Cosmetics Co., Ltd. Dev. Area, Hangzhou Economic; 755 Nongken Road, Hangzhou, Zhejiang CHINA	CHINA
Sept 14, 2017	Shanghai Weierya Daily Chemicals Factory No. 1072 Dongsheng Lu, Shanghai, Shanghai CHINA	CHINA
Sept 28, 2017	Delta Laboratories Pty Ltd 8 Warringah CL , Somersby, New South Wales AUSTRALIA	AUSTRALIA
IMPORT ALERT 66-41, Detention Without Physical Examination of Unapproved New Drugs Promoted in the United States
Sept 13, 2017	Drogueria Y Laboratorio Butter Pharma Division De Koret Sa D
Sept 13, 2017	laboratorio Butter Pharma Carretera Comalapa Km 12 1/2, San Marcos, EL SALVADOR	EL SALVADOR
Sept 19, 2017	Turkuaz Medikal Kozmetik Ve No:34/3 Yakuplu Mahallesi Beysan, Istanbul, TURKEY	Turkey
Sept 29, 2017	LMZ INTERNATIONAL LTD NO 2 Changfeng Road Liuzhou Guangxi , Liuzhou, Guangxi CHINA	CHINA
IMPORT ALERT 99-32, detention without physical examination of products from firms refusing FDA foreign establishment inspection
Sept 13, 2017	Alex Industries Plot No 9109/4-5 Gidc Industrial Estate, Nr. Ion Exchange, Kanoria Chemical Road, Ankleshwar, Gujarat INDIA	INDIA
Sept 19, 2017	Tianjin Zhongxin Pharmaceutical Group Corp., Ltd. Longshunrong Pharmaceutical Factory , NO. 21 10th Avenue, Teda , Tianjin, Tianjin CHINA	China
Sept 28, 2017	Hubei Merryclin Pharmaceutical Co., Ltd. Yunmeng , 8 Heping Road; Economic Development Zone , Xiaogan, Hubei CHINA	CHINA
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:

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.”