博文
2017年FDA药品召回一览表
|||
2017年FDA药品召回一览表
诸平
据 FDA官网 （ http://www.fda.org）2017年5月17日提供的最新公布结果，自2017年1月24日以来(截止2017年5月17日)，FDA已经公布药品召回(Drug Recalls)15次，召回药品一览表见如下：
| Date | Brand Name | Product Description | Reason/ Problem | Company | ||
|---|---|---|---|---|---|---|
| 01/24/2017 | Hospira, Inc. | Vancomycin Hydrochloride for injection | Particulate matter | Hospira, Inc. | ||
| 02/08/2017 | X-Gen | Ibuprofen Lysine Injection, 20 mg/2 mL | Presence of particulate matter | Exela Pharma Sciences, LLC | ||
| 02/14/2017 | Synergy Rx Pharmacy | Human Chorionic Gonadotropin (HCG) for injection | Lack of Sterility Assurance | Synergy Rx Pharmacy | ||
| 02/17/2017 | Synergy Rx Pharmacy | Non-sterile drug products | Lack of Quality Assurance | Synergy Rx Pharmacy | ||
| 02/23/2017 | Advanced Pharma | All unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location | Products may contain synthetic latex and/or natural latex | Avella Specialty Pharmacy | ||
| 02/24/2017 | Edex | Alprostadil for injection | Potential Lack of Sterility Assurance | Endo Pharmaceuticals Inc. | ||
| 03/28/2017 | LaBri’s Body Health | Dietary Supplement | Unapproved new drug | Envy Me | ||
| 03/31/2017 | Mylan | EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors | Failure to activate the device due to a potential defect | Mylan N.V. | ||
| 04/06/2017 | Isomeric Pharmacy Solutions | Multiple compounded sterile products | Concerns of lack of sterility assurance | Isomeric Pharmacy Solutions | ||
| 04/13/2017 | Hyland's | Baby teething tablets and Nightime teething tablets | Contains inconsistent amounts of belladonna alkaloids | Standard Homeopathic Company |
| 04/18/2017 | Uproar, Cummor, Zrect, Monkey Business and others | Dietary Supplement | Unapproved new drug | Organic Herbal Supply, Inc. |
| 04/21/2017 | C.O. Truxton, Inc. | Phenobarbital Tablets, USP, 15 mg | Product may contain 30 mg tablets | C.O. Truxton, Inc. |
| 04/21/2017 | Hospira, Inc. | 25% Dextrose Injection, USP (Infant) | Particulate matter (human hair) | Hospira, Inc. |
| 05/05/2017 | GEC Laxoplex | Marketed as a dietary supplement | Presence of anabolic steroids | Genetic Edge Compounds |
| 05/08/2017 | Truxton Incorporated | Amitriptyline HCL Tablets, USP 50mg and Phenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg | Labeling mix-up | C.O. Truxton, Inc. |
更多药品召回信息请浏览FDA官网：
Recalls for all FDA-regulated products
For recall notices older than 60 days, see the Recall and Safety Alerts Archive.
https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm
https://blog.sciencenet.cn/blog-212210-1055633.html
上一篇：2017年FDA批准新药名单
下一篇：关注钛、钛合金的市场行情变化
