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
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
June 7, 2017 Jiangmen Nowadays Daily Goods Co., Ltd.
Boyukou Liangde Chong, Jiangmen, Guangdong CHINA
June 29, 2017 Bicooya Cosmetics Limited
NO 17 Yanhu Lu, Yiwu, Jinhua, Zhejiang CHINA
IMPORT ALERT 66-41, Detention Without Physical Examination of Unapproved New Drugs Promoted in the United States
June 2, 2017 Meyer Organics Pvt Ltd
10d 2nd Phase, Peenya Ind Area, Karnataka, INDIA
June 9, 2017 Natural Vitality
11 Aldinga St, Brendale, Queensland AUSTRALIA
June 12, 2017 Naticura Inc.
249 Hillhurst Blvd, North York, Ontario CANADA
Prado Norte 470 Piso 4, Col. MIGUEL HIDALGO, Hidalgo, Nuevo Leon MEXICO
June 19, 2017 Cosbel Sa De Cv

Felix Cuevas No. 6, Col Tlacoquemecatl De, Benito Juarez 621024-89, MEXICO

June 22, 2017 Deltas Pharma ( Padmavati )
Old Industrial Area , Haridwar, INDIA
June 22, 2017 Padmavati Pharmaceuticals
F/52 Industrial Area, Haridwar, INDIA
June 29, 2017 HCR Formulations P Ltd
A – 38 Mahagujarat Estate , Sarkhej – Bavla Highway , Moraiya, Gujarat INDIA
IMPORT ALERT 99-32, detention without physical examination of products from firms refusing FDA foreign establishment inspection
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 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.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact me if you ever have questions at tony@fdazilla.com.

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