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 FirmClassProduct(s) Reason
Complete Pharmacy and Medical Solutions LLCI3 injectable productsNon-sterility: presence of mold confirmed by outside laboratory at the 14-day culture
Safecor Health, LLCII6 productsCGMP Deviations
HospiraIILevophed norepinephrine bitartrate, injection,GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Bausch & Lomb, IncIINasalCrom (cromolyn sodium) Nasal SprayCGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot
American Pharmaceutical Ingredients LLCIIESTRONE USPcGMP Deviations; lack of quality assurance.
SCA PharmaceuticalsII10 productsLack of assurance of sterility: Product bags leaking at seam
Forest LaboratoriesIISaphris 10 mg (asenapine) sublingual tabletsLabeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
QualgenII8 compounded products.CGMP deviations- Lack of Quality Assurance
Dr. Reddy’s LaboratoriesII4 strengths Zenatane (isotretinoin) CapsulesFailed Dissolution Specifications: out of specification results observed for low dissolution
L. PerrigoIIOption 2, emergency contraceptiveDefective Container: Carton is missing the tablet blister strip and tablet.
Spectrum Laboatory ProductsII2 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, LLCIImethylcobalamin 1mg/1mL, vial for injection, Rx onlyLack of Assurance of Sterility
Lucid Pharma LLCIIVenlafaxine Hydrochloride Extended-Release Capsules USPFailed Tablet/Capsules Specifications: pharmacist complaints for bottles containing melted capsules.
Vi-Jon Inc.IIMagnesium Citrate Saline Laxative Cherry FlavoredPresence of foreign substance: glass particle
VistaPharmIIINystatin Oral SuspensionFailed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Sandoz IncIIIAmoxicillin and Clavulanate Potassium Tablets, USPSubpotent Drug; Clavulanic Acid
MylanIIIMontelukast Sodium Oral Granules, 4 mg pouchFailed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Pharmedium Services LLCIII10 productsLabeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Unclassified Recalls for June, 2017

Recalling FirmProduct(s)Reason
AlvogenClindamycin Inj ADD-Vantage vialsmicrobial 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 PharmaThe 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 ServicesSuccinylcholine Chloride 20mg/mL 5 mL syringeThe 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 CompanyEliquiscustomer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets
Phillips Company9 different topical antibiotic productsan 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.
TevaPaliperidone ER Tablets 3mgDissolution test failure
Advanced PharmaNitroglycerin Injection in 5% Dextroselaboratory test results indicating a lower than expected potency on certain lots of compounded NitroGlycerin Injection
Hospira4 productsLack 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 Servicesspecific lots of Potassium Phosphate and Succinylcholine Chloridevoluntary 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.
DateCompany and AddressCountry
IMPORT ALERT 66-40, Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs
June 2, 2017Cellex-C International Inc. 9 New St, Toronto, Ontario CANADACanada
June 7, 2017Jiangmen Nowadays Daily Goods Co., Ltd. Boyukou Liangde Chong, Jiangmen, Guangdong CHINAChina
June 29, 2017Bicooya Cosmetics Limited NO 17 Yanhu Lu, Yiwu, Jinhua, Zhejiang CHINACHINA
IMPORT ALERT 66-41, Detention Without Physical Examination of Unapproved New Drugs Promoted in the United States
June 2, 2017Meyer Organics Pvt Ltd 10d 2nd Phase, Peenya Ind Area, Karnataka, INDIAIndia
June 9, 2017Natural Vitality 11 Aldinga St, Brendale, Queensland AUSTRALIAAustralia
June 12, 2017Naticura Inc. 249 Hillhurst Blvd, North York, Ontario CANADACANADA
June 14, 2017SMEDICAL HEALTH AND BEAUTY S DE Prado Norte 470 Piso 4, Col. MIGUEL HIDALGO, Hidalgo, Nuevo Leon MEXICOMEXICO
June 19, 2017Cosbel Sa De Cv Felix Cuevas No. 6, Col Tlacoquemecatl De, Benito Juarez 621024-89, MEXICOMEXICO
June 22, 2017Deltas Pharma ( Padmavati ) Old Industrial Area , Haridwar, INDIAINDIA
June 22, 2017Padmavati Pharmaceuticals F/52 Industrial Area, Haridwar, INDIAINDIA
June 29, 2017HCR Formulations P Ltd A – 38 Mahagujarat Estate , Sarkhej – Bavla Highway , Moraiya, Gujarat INDIAINDIA
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.