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 

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.”

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