Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month!
Recalls for May 2017
| Recalling Firm | Class | Product(s) | Reason |
| Meridian Medical Technologies (a Pfizer Company) | I | EpiPen 2-pak and EpiPen Jr 2-pak | Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication |
| Envy Me | I | LaBri’s Body Health Atomic, capsules | Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine. |
| Standard Homeopathic Company | I | 2 presentations of Hyland’s Baby Nighttime Teething Tablets | Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the productlabels. |
| Hospira | I | Infant 25% Dextrose Inj. | Presence of Particulate Matter: human hair found within an internal sample syringe |
| Teva Pharmaceuticals | II | Clozapine Tablets USP | Microbial Contamination of Non-Sterile Products |
| PAR Sterile Products LLC | II | Buprenorphine HCI Injection | Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component |
| Amneal Pharmaceuticals LLC | II | Rabeprazole sodium delayed release tablets | Failed Dissolution Specifications |
| The Harvard Drug Group | II | 2 strengths fluconazole tablets | Failed dissolution Specifications |
| Key Pharmacy and Compounding Center | II | ~ 80 injectable products | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. |
| Baxter Healthcare | II | Fluconazole Injection, USP and Milrinone Lactate in 5% Dextrose Injection | Lack of assurance of sterility: customer complaints received for the presence of leaks |
| Akorn Inc | II | Sulfamethoxazole and Trimethoprim Oral suspension | Failed Dissolution Specifications |
| Mylan Pharmaceuticals | II | Alprazolam Extended release tablets | Failed Dissolution Specifications |
| Advanced Pharma Inc | II | 59 products, all lots within expiry | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. |
| Fargon Inc. | II | 2 products | CGMP Deviations: lack of quality assurance at the API manufacturer |
| Cell Distributors | II | Refresh Tears | Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel |
| Sato Pharmaceuticals Co Ltd | II | 3 presentations of Optic Splash (naphazoline hydrochloride) Eye Drops, | Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas |
| Gentell, Inc | II | Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole | GMP Deviations; product may not meet cGMP requirements |
| GlaxoSmithKline, LLC | II | Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation | Defective Delivery System: Elevated number of units with out of specification results for leak rate |
| P&L Development LLC | III | Diphenhydraamine HCl softgels | Subpotent: This product is being recalled due to low out of specification assay results at the 9-month time point |
| Fagron Inc | III | Zinc Oxide Paste | Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container. |
| The Harvard Drug Group | III | Aripiprazole Tblets | Superpotent Drug; out of specification results for assay (manufacturer) |
| Sun Pharmaceuticals | III | 4 strengths Olanzapine tablets | Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). |
| Teva Pharmaceuticals | III | PrednisoLONE Oral Solution USP | Failed stability specifications |
| Sanofi-Aventis | III | Mozobil (plerixafor injection) | Labeling: Incorrect or Missing Package Insert |
| Akorn Inc | III | IC-Green (indocyanine green for injection, USP | Product is being recalled due to low pH value |
| Teligent, Inc | III | Desoximetasone Ointment USP | Superpotent drug |
| Taro Pharmaceuticals U.S. A | III | Fluocinonide Cream | Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate |
| Mylan Pharmaceuticals Inc. | III | Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), | Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room. |
| Sun Pharmaceuticals Industries | III | Children’s Cetirizine Hydrochloride Chewable Tablets | Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness. |
| Qualitest Pharmaceticals | III | HYDROCORTISONE LOTION, USP, 2.5% | Superpotent Drug: above specification for the assay. |
| Mylan | III | Norethindrone Acetate and Ethinyl Estradiol Tablets, USP | Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room |
| Strides Pharma INC | III | Benzonatate capsules | Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content |
Unclassified Recalls for May, 2017
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| Recalling Firm | Product(s) | Reason |
| AstraZeneca | Brilanta | A professional sample bottle containing eight tablets of Brilinta 90mg also contained another medicine called Zurampic (lesinurad) 200 mg tablets which is also manufactured by AstraZeneca. |
| Lupin | Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) | …packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets. |
| Hospira | 1 lot 25% dextrose solution pre-filled syringe. | presence of particulate matter, identified as human hair, found within an internal sample syringe. |
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 |
| May 18, 2017 | Guangzhou Xiubo Medical Equipment Co. Ltd No. 22 Tian Yuan Road, Baiyun District, Guangzhou, Guangdong CHINA | CHINA |
| May 19, 2017 | Suzhou Kangli Orthopaedics Instrument Co., Ltd. Hedonglu, Zhangjiagang, Suzhou, Jiangsu CHINA | CHINA |
| My 22, 2017 | Hebei Pukang Medical Instruments Co., Ltd. Dongshiduan Town, Xushui County, Baoding, Hebei CHINA | CHINA |
| IMPORT ALERT 66-40, Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs | ||
| May 11, 2017 | Firson Co., Ltd. Seobuk-Gu, 47 Handeul 1-ro, Seobuk-gu, Cheonan-si, Chungcheongnam-do KOREA, REPUBLIC OF (SOUTH) | South Korea |
| May 23, 2017 | Foshan Flying Medical Products Co., Ltd. No. 49 Xiangshan 2th Road, Fengtain Industrial District, Foshan, Guangdong CHINA | CHINA |
| IMPORT ALERT 66-41, Detention Without Physical Examination of Unapproved New Drugs Promoted in the United States | ||
| May 5, 2017 | Nugale Pharmaceutical Inc. 41 Pullman Crt., Scarborough, Ontario CANADA | CANADA |
| My 10, 2017 | Viva Pharmaceutical Inc 13880 Viking Pl, Richmond, British Columbia CANADA | CANADA |
| May 18, 2017 | P T Eagle Indo Pharmaceutical laboratories Unknown Street, Jakarta, INDONESIA | INDONESIA |
| May 18, 2017 | PT Eagle Indo Pharmaceutical Laboratories Km. 1.1, JL Raya Siliwangi, Tangerang, Jabotabek INDONESIA | INDONESIA |
| May 26, 2017 | NNS ORGANICS LIMITED Dba Nova Scotia Organic, 2769 Lawrencetown Rd, Lawrencetown, Nova Scotia CANADA | Canada |
| May 26, 2017 | NNS Organics Health Products Limited 2769 Lawrencetown Road, Lawrencetown, NS CANADA | Canada |
| May 31, 2017 | Patanjali Ayurved Ltd. 132, Village – Aurenjebpur, Roorkee, 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.