FDA issued 47 Product Recalls, Import Alerts, and Consent Decrees in May 2017

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

Recalls for May 2017

Recalling Firm Class Product(s) Reason
Meridian Medical Technologies (a Pfizer Company) I EpiPen 2-pak and EpiPen Jr 2-pak Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Envy Me I LaBri’s Body Health Atomic, capsules Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
Standard Homeopathic Company I 2 presentations of Hyland’s Baby Nighttime Teething Tablets Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the productlabels.
Hospira I Infant 25% Dextrose Inj. Presence of Particulate Matter: human hair found within an internal sample syringe
Teva Pharmaceuticals II Clozapine Tablets USP Microbial Contamination of Non-Sterile Products
PAR Sterile Products LLC II Buprenorphine HCI Injection Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component
Amneal Pharmaceuticals LLC II Rabeprazole sodium delayed release tablets Failed Dissolution Specifications
The Harvard Drug Group II 2 strengths fluconazole tablets Failed dissolution Specifications
Key Pharmacy and Compounding Center II ~ 80 injectable products Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Baxter Healthcare II Fluconazole Injection, USP and Milrinone Lactate in 5% Dextrose Injection Lack of assurance of sterility: customer complaints received for the presence of leaks
Akorn Inc II Sulfamethoxazole and Trimethoprim Oral suspension Failed Dissolution Specifications
Mylan Pharmaceuticals II Alprazolam Extended release tablets Failed Dissolution Specifications
Advanced Pharma Inc II 59 products, all lots within expiry Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Fargon Inc. II 2 products CGMP Deviations: lack of quality assurance at the API manufacturer
Cell Distributors II Refresh Tears Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel
Sato Pharmaceuticals Co Ltd II 3 presentations of Optic Splash (naphazoline hydrochloride) Eye Drops, Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas
Gentell, Inc II Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole GMP Deviations; product may not meet cGMP requirements
GlaxoSmithKline, LLC II Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation Defective Delivery System: Elevated number of units with out of specification results for leak rate
P&L Development LLC III Diphenhydraamine HCl softgels Subpotent: This product is being recalled due to low out of specification assay results at the 9-month time point
Fagron Inc III Zinc Oxide Paste Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
The Harvard Drug Group III Aripiprazole Tblets Superpotent Drug; out of specification results for assay (manufacturer)
Sun Pharmaceuticals III 4 strengths Olanzapine tablets Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Teva Pharmaceuticals III PrednisoLONE Oral Solution USP Failed stability specifications
Sanofi-Aventis III Mozobil (plerixafor injection) Labeling:   Incorrect or Missing Package Insert
Akorn Inc III IC-Green (indocyanine green for injection, USP Product is being recalled due to low pH value
Teligent, Inc III Desoximetasone Ointment USP Superpotent drug
Taro Pharmaceuticals U.S. A III Fluocinonide Cream Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate
Mylan Pharmaceuticals Inc. III Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Sun Pharmaceuticals Industries III Children’s Cetirizine Hydrochloride Chewable Tablets Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Qualitest Pharmaceticals III HYDROCORTISONE LOTION, USP, 2.5% Superpotent Drug: above specification for the assay.
Mylan III Norethindrone Acetate and Ethinyl Estradiol Tablets, USP Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room
Strides Pharma INC III Benzonatate capsules Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content


Unclassified Recalls
for May, 2017

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Recalling Firm Product(s) Reason
AstraZeneca Brilanta a professional sample bottle containing eight tablets of Brilinta 90mg also contained another medicine called Zurampic (lesinurad) 200 mg tablets which is also manufactured by AstraZeneca.
Lupin Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) …packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets.
Hospira 1 lot 25% dextrose solution pre-filled syringe. presence of particulate matter, identified as human hair, found within an internal sample syringe.

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
May 18, 2017 Guangzhou Xiubo Medical Equipment Co. Ltd

No. 22 Tian Yuan Road, Baiyun District, Guangzhou, Guangdong CHINA

CHINA
May 19, 2017 Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Hedonglu, Zhangjiagang, Suzhou, Jiangsu CHINA
CHINA
My 22, 2017 Hebei Pukang Medical Instruments Co., Ltd.
Dongshiduan Town, Xushui County, Baoding, Hebei CHINA
CHINA
IMPORT ALERT 66-40, Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs
May 11, 2017 Firson Co., Ltd.
Seobuk-Gu, 47 Handeul 1-ro, Seobuk-gu, Cheonan-si, Chungcheongnam-do KOREA, REPUBLIC OF (SOUTH)
South Korea
May 23, 2017 Foshan Flying Medical Products Co., Ltd.
No. 49 Xiangshan 2th Road, Fengtain Industrial District, Foshan, Guangdong CHINA
CHINA
IMPORT ALERT 66-41, Detention Without Physical Examination of Unapproved New Drugs Promoted in the United States
May 5, 2017 Nugale Pharmaceutical Inc.
41 Pullman Crt., Scarborough, Ontario CANADA
CANADA
My 10, 2017 Viva Pharmaceutical Inc

13880 Viking Pl, Richmond, British Columbia CANADA

CANADA
May 18, 2017 P T Eagle Indo Pharmaceutical laboratories
Unknown Street, Jakarta, INDONESIA
INDONESIA
May 18, 2017 PT Eagle Indo Pharmaceutical Laboratories
Km. 1.1, JL Raya Siliwangi, Tangerang, Jabotabek INDONESIA
INDONESIA
May 26, 2017 NNS ORGANICS LIMITED
Dba Nova Scotia Organic, 2769 Lawrencetown Rd, Lawrencetown, Nova Scotia CANADA
Canada
May 26, 2017 NNS Organics Health Products Limited
2769 Lawrencetown Road, Lawrencetown, NS CANADA
Canada
May 31, 2017 Patanjali Ayurved Ltd.
132, Village – Aurenjebpur, Roorkee, INDIA
INDIA
IMPORT ALERT 99-32, detention without physical examination of products from firms refusing FDA foreign establishment inspection
NONE THIS MONTH
IMPORT ALERT 99-34, Detention Without Physical Examination of Drugs or Medical Devices for Firms without a Valid Drug or Medical Device Registration
NONE THIS MONTH
IMPORT ALERT 89-16 Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspections
NONE THIS MONTH
IMPORT ALERT 66-57: Detention Without Physical Examination of Foreign manufactured Unapproved Prescription Drugs Promoted to Individuals in the U. S
NONE THIS MONTH

Corporate Integrity Agreements: none this month

Consent Decree Agreement: none this month

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