Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month!
Recalls for August, 2017
| Recalling Firm | Class | Product(s) | Reason |
| C.O. Truxton | I | 6 products | Labeling: Labeled mix up, potentially mislabeled |
| Brian P. Richardson | I | CaverFlo Natural Herbal Coffee | Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk |
| Genetic Edge Compounds | I | GEC LX Laxoplex 60 capsules Dietary Supplement | Marketed Without an Approved NDA/ANDA: Tainted Product Marketed as a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances. |
| Lupin Limited | I | Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets | Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package. |
| Dynamic Technical Formulations | I | Biotech Underground Tri-Ton Hardcore Formula capsules | Marketed Without an Approved NDA/ANDA: Tainted Product Marketed as a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine. |
| Hardcore Formulations | I | 2 products, all lots within expiry | Marketed Without an Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine. |
| The Harvard Drug Group | II | 5 products | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination |
| Bayer HealthCare Pharmaceuticals | II | 3 strengths Alka-Seltzer Original | Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. |
| Hospira a Pfizer Company | II | 4 injectable products | Lack of Sterility Assurance |
| Time-Cap Laboratories, Inc. | II | Ibuprofen Tablets | Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg |
| Apace KY LLC | II | 2 product recalls | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg |
| At Home Medical Inc | II | Oxygen, refrigerated Liquid USP | GMP Deviations: The firm does not include an SOP for testing for out of specifications. |
| Cantrell Drug Company | II | 17 products | Lack of sterility assurance |
| X-Gen Pharmaceutical | II | Nystatin Topical Powder | Presence of Foreign Substance: potential presence of plastic particles. |
| Hospira | II | 3 strengths, Hydromorphone Hydrochloride Injection, USP | Presence of Particulate Matter: Silicone oil |
| VistaPharm, Inc. | II | 2 strengths Lactulose Solution, USP | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. |
| Zydus Pharmaceuticals USA Inc | II | 3 strengths Divalproex Sodium Delayed Release Tablets, USP | Failed Dissolution Specifications |
| Precision Dose Inc | II | Carbamazepine Oral Suspension | Labeling Error: Label mix-up. Products’ unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC |
| Fusion IV Pharmaceuticals | II | Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles | CGMP Deviations |
| Vi-Jon Inc. | II | Magnesium Citrate Oral Solution | Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis |
| Teva | II | Famotidine Tablets | Failed Tablet/Capsule Specification; out of specification for tablet weight |
| PD-Rx Phrmaceuticals | II | Famotidine Tablets | Failed Tablet/Capsule Specification; out of specification for tablet weight |
| Global Marketing Enterprises | II | Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine | Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use. |
| ICU Medical Inc. | II | 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container | Presence of Particulate Matter; stainless steel |
| Amgen | II | Procrit Epoetin Alfa 40,000 units/mL single use vial | Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials |
| Teva | III | Albuterol Sulfate Inhalation Solution | Failed Impurities/Degradation Specifications: high out of specification results for related compound D |
| Dr. Reddy’s Laboatories, Inc. | III | Pravastatin Sodium Tablets, USP | Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220 |
| Teva Pharmaceuticals | III | Glipizide Extended-Release Tablets | Failed Moisture Limits: out of specification test results for water content obtained during stability testing |
| Akorn Inc | III | 2 kit types, Halyard 24-Hour Oral Care Kit | Crystallization with subpotent out of specification assay results for chlorhexidine. |
| AVKARE Inc. | III | Voriconazole Tablets, 200 mg, 20-count cartons | Failed impurities/degradation specifications: Out of specification for a related compound C. |
| Linde Eckstein Gmbh + Co | III | Fourteen products | subpotent |
| KVK-Tech Inc | III | Phentermine HCL Capsules, USP 15 mg | Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30-month Room Temperature Retained Sample stability test. |
Unclassified Recalls or Alerts for the Month of August
| Recalling Firm | Product(s) | Reason | |
| Teva Pharmaceuticals | III | Failed Moisture Limits: out of specification test results for water content obtained during stability testing | |
| Vital Rx Inc, dba Atlantic Pharmacy and Compounding (a compounding pharmacy) | All sterile products | On July 31, 2017, FDA recommended that Atlantic Pharmacy cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile. The company has not yet initiated a recall. Therefore, FDA is alerting health care professionals and patients to dispose of and not use drug products. | |
| PharmaTech again | Liquid drug products distributed by Rugby and others. The press release has specifics. | FDA avdvisory — Not to Use due to Burkholderia cepacia contamination and the potential for severe patient infection | |
| International Laboratories | Pravastatin Sodium tablets | The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets. | |
| Amneal Pharmaceuticals | Lorazepam oral concentrate | In a few instances, the dropper is printed with the dose markings in reverse number order, has no dose markings or has dose markings that are shifted. | |
| Vital Rx Inc | Recalling all lots of all compounded injectable prescription medications to the consumer level. | The compounded injectable prescription medications have been found to lack sterility assurance. | |
| Mid-Valley Pharmaceutical | Doctor Manzanilla Cough & Cold AND Doctor Manzanilla Allergy & Decongestant Relief Syrup | Potential contamination with Burkholderia cepacian | |
| Hospira | Vancomycin Injection | Confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial. | |
| Hospira | Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and Levophed® (Norepinephrine Bitartrate Injection, USP) | Potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. | |
| PharMEDium | All unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 | Laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered. | |
| Foshan Flying Medical Products Warning Letter issued August 1, 2017; firm placed on import alert on May 23, 2017 for failure to meet GMPs. | Alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues | NOTICE TO HEALTHCARE PROFESSIONALS, firm refuses to conduct a recall. Products lack sterility assurance and inspection revealed other quality issues. | |
| Bella Pharmaceuticals (compounding pharmacy) | All lots of unexpired sterile drug products | Lack of sterility assurance | |
| Centurion Labs | Ninjacof and Ninjakof A | Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Partech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia. |
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FDA Import Alerts
| IMPORT ALERT 89-04, Detention Without Physical Examination of Devices from Firms that Have Not Met GMPs. | ||
| Date | Company and Address | Country |
| NONE | ||
| IMPORT ALERT 66-40, Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs | ||
| August 11, 2017 | Changzhou Anyuan Import & Export Fuchen Garden Suite, 1-403; Xinbei District, Changzhou, Jiangsu CHINA | CHINA |
| August 11, 2017 | Yicheng Chemical Corp. Fuchen Garden Suite, 1-402; Xinbei District, Changzhou, Jiangsu CHINA | CHINA |
| August 23, 2017 | Amaros Co., Ltd Jungwon-gu, 560 Dunchon-daero, Seongnam-si, KOREA, REPUBLIC OF (SOUTH) | South Korea |
| August 23, 2017 | Seindni Co., Ltd. Seongbuk-gu, 610-304 16, Gireum-ro, Seoul, KOREA, REPUBLIC OF (SOUTH) | South Korea |
| Aug 25, 2017 | Mahendra Chemicals B – 1 217 218 2 G I D C Estate, Ahmedabad, Gujarat INDIA | INDIA |
| IMPORT ALERT 66-41, Detention Without Physical Examination of Unapproved New Drugs Promoted in the United States | ||
| August 4, 2017 | Israel Post Co 217, Jaffa Ro, Jerusalem, ISRAEL | ISRAEL |
| August 4, 2017 | Royal Sea Kehilat Lodge 18 , Tel Aviv, ISRAEL | ISRAEL |
| August 9, 2017 | So Young Plus Pusat Perdagangan Bukit Serdang Jalan BS 14/1 , Suite #111, C-G-23 , Seri Kembangan, Selangor Darul Ehsan MALAYSIA | MALAYSIA |
| August 9, 2017 | Syarikat Wen Ken Drug Sdn Bhd Jalan a, Johor Bahru, Johor MALAYSIA | MALAYSIA |
| August 11, 2017 | Keasri Ayurvedic Pharmacy Abrama, VIA Vedchha , Gujarat, INDIA | India |
| August 11, 2017 | Cafe Del Pacifico Sa De Cv Blvd Enrique Mazon Lopez 626 , Hermosillohermosillo, MEXICO | MEXICO |
| August 14, 2017 | RIGHTEOUS DRAGON MANAGEMENT GROU 7F, KOWLOON BLDG, 555 N, HONG KONG, CHINA | CHINA |
| August 14, 2017 | SG (CHINA) No. 26 Jianguomen Eni Da Jie, 5th Floor, Beijing News Plaza, Beijing, Tianjin, CHINA | CHINA |
| August 16, 2017 | NuEra Nutraceutical Inc 12031 No. 5 Rd, Richmond, British Columbia CANADA | CANADA |
| August 16, 2017 | INKA FOREST EXPORT Asoc San Francisco, Lima, PERU | PERU |
| August 21, 2017 | SHENZHEN TWOSUCCESS ELECTRONICS Room 508, Ruida Science, Shenzhen City, CHINA | China |
| August 21, 2017 | Shenzhen Keshangda Electronics Technology Co., Ltd. 6 Bld, Shantang Industrial Park Paibang Village, Henggang Town Longgang Dist., Shenzhen, Guangdong CHINA | China |
| Aug 25, 2017 | NEW LIFE NATURAL VEGETATION CELL Lucaya Shopping Cent 14, Freeport City, BAHAMAS | Bahamas |
| Aug 25, 2017 | Biocell SARL 48 avenue Jeanne, Soisy sous Montmorency, Val d’Oise FRANCE | France |
| Aug 25, 2017 | UNIQUE FRAGRANCES Plot No, 21 Road No 1, New Delhi, Delhi INDIA | India |
| IMPORT ALERT 99-32, Detention without physical examination of products from firms refusing FDA foreign establishment inspection | ||
| NONE | ||
| IMPORT ALERT 99-34, Detention Without Physical Examination of Drugs or Medical Devices for Firms without a Valid Drug or Medical Device Registration | ||
| NONE | ||
| IMPORT ALERT 89-16 Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspections | ||
| NONE | ||
| IMPORT ALERT 66-57: Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Promoted to Individuals in the U. S | ||
| NONE |
Corporate Integrity Agreements:
- Mylan Inc. and Mylan Specialty L.P. (Canonsburg, PA) signed a corporate integrity agreement on August 16, 2017.