FDA issued 39 Product Recalls, Import Alerts, and Consent Decrees in June 2017

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

Recalls for the month June 2017

Recalling Firm	Class	Product(s)	Reason
Complete Pharmacy and Medical Solutions LLC	I	3 injectable products	Non-sterility: presence of mold confirmed by outside laboratory at the 14-day culture
Safecor Health, LLC	II	6 products	CGMP Deviations
Hospira	II	Levophed norepinephrine bitartrate, injection,	GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Bausch & Lomb, Inc	II	NasalCrom (cromolyn sodium) Nasal Spray	CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot
American Pharmaceutical Ingredients LLC	II	ESTRONE USP	cGMP Deviations; lack of quality assurance.
SCA Pharmaceuticals	II	10 products	Lack of assurance of sterility: Product bags leaking at seam
Forest Laboratories	II	Saphris 10 mg (asenapine) sublingual tablets	Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Qualgen	II	8 compounded products.	CGMP deviations- Lack of Quality Assurance
Dr. Reddy’s Laboratories	II	4 strengths Zenatane (isotretinoin) Capsules	Failed Dissolution Specifications: out of specification results observed for low dissolution
L. Perrigo	II	Option 2, emergency contraceptive	Defective Container: Carton is missing the tablet blister strip and tablet.
Spectrum Laboatory Products	II	2 presentations Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient,	CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection
MedPark Pharmacy, LLC	II	methylcobalamin 1mg/1mL, vial for injection, Rx only	Lack of Assurance of Sterility
Lucid Pharma LLC	II	Venlafaxine Hydrochloride Extended-Release Capsules USP	Failed Tablet/Capsules Specifications: pharmacist complaints for bottles containing melted capsules.
Vi-Jon Inc.	II	Magnesium Citrate Saline Laxative Cherry Flavored	Presence of foreign substance: glass particle
VistaPharm	III	Nystatin Oral Suspension	Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Sandoz Inc	III	Amoxicillin and Clavulanate Potassium Tablets, USP	Subpotent Drug; Clavulanic Acid
Mylan	III	Montelukast Sodium Oral Granules, 4 mg pouch	Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Pharmedium Services LLC	III	10 products	Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Unclassified Recalls for June, 2017

Recalling Firm	Product(s)	Reason
Alvogen	Clindamycin Inj ADD-Vantage vials	microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company.
Advanced Pharma		The products being recalled by Advanced Pharma were repackaged and/or compounded at its Houston, Texas facility using certain Hospira products. The recalled products are specific lots of Potassium Phosphate and Succinylcholine Chloride. This is a secondary recall based on a Hospira’s recent recall.
Fargon Sterile Services	Succinylcholine Chloride 20mg/mL 5 mL syringe	The secondary recall of product manufactured by Hospira Inc., a Pfizer company, and repacked by Fagron Sterile Services, is due to microbial growth detected during a routine simulation of Hospira’s manufacturing process, which represents the potential introduction of microorganisms into the product. To date, there have been no reports of adverse events
Bristol-Myers Squibb Company	Eliquis	customer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets
Phillips Company	9 different topical antibiotic products	an FDA inspection found significant manufacturing practices that calls into question the safety, identity, strength, quality and purity of unexpired drug products made at the firm during the past three years.
Teva	Paliperidone ER Tablets 3mg	Dissolution test failure
Advanced Pharma	Nitroglycerin Injection in 5% Dextrose	laboratory test results indicating a lower than expected potency on certain lots of compounded NitroGlycerin Injection
Hospira	4 products	Lack of sterility assurance based on microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Homidium Services	specific lots of Potassium Phosphate and Succinylcholine Chloride	voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance.

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
	NONE THIS MONTH
IMPORT ALERT 66-40, Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs
June 2, 2017	Cellex-C International Inc. 9 New St, Toronto, Ontario CANADA	Canada
June 7, 2017	Jiangmen Nowadays Daily Goods Co., Ltd. Boyukou Liangde Chong, Jiangmen, Guangdong CHINA	China
June 29, 2017	Bicooya Cosmetics Limited NO 17 Yanhu Lu, Yiwu, Jinhua, Zhejiang CHINA	CHINA
IMPORT ALERT 66-41, Detention Without Physical Examination of Unapproved New Drugs Promoted in the United States
June 2, 2017	YASCO SEAFOODS 67-68 ECCLES INDUSTRIAL SITE, 19 WATER STREET, EAST BANK DEMERARA, GY-NOTA GUYANA	Guyana
June 2, 2017	Meyer Organics Pvt Ltd 10d 2nd Phase, Peenya Ind Area, Karnataka, INDIA	India
June 9, 2017	Natural Vitality 11 Aldinga St, Brendale, Queensland AUSTRALIA	Australia
June 12, 2017	Naticura Inc. 249 Hillhurst Blvd, North York, Ontario CANADA	CANADA
June 14, 2017	SMEDICAL HEALTH AND BEAUTY S DE Prado Norte 470 Piso 4, Col. MIGUEL HIDALGO, Hidalgo, Nuevo Leon MEXICO	MEXICO
June 19, 2017	Cosbel Sa De Cv Felix Cuevas No. 6, Col Tlacoquemecatl De, Benito Juarez 621024-89, MEXICO	MEXICO
June 22, 2017	Deltas Pharma ( Padmavati ) Old Industrial Area , Haridwar, INDIA	INDIA
June 22, 2017	Padmavati Pharmaceuticals F/52 Industrial Area, Haridwar, INDIA	INDIA
June 29, 2017	HCR Formulations P Ltd A – 38 Mahagujarat Estate , Sarkhej – Bavla Highway , Moraiya, Gujarat 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:

US District Judge in the Southern District of Florida entered a consent decree agreement between the US and Stratus Pharmaceutical, Sonar Product of NJ and two of the companies’ officers. Federal Marshalls seized unapproved prescription drug products valued at more than $16 million.