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.