ST LOUIS (MD Consult) - On October 27, 2010, the US Food and Drug Adminstration (FDA) announced that Sandoz has initiated a voluntary recall of all 50-mg/2 mL and 250-mg/10 mL vials of Sandoz and Parenta brand injectable methotrexate to the consumer/user level in the United States. Sandoz quality control has found small flakes of glass in a limited number of vials in 4 lots of the product. The company has determined that this finding is a result of delamination of the glass used to manufacture the vials.
Parenteral injection of the drug from the affected lots could lead to serious adverse events, resulting in disability and death. Additionally, neurologic damage could result from intrathecal administration. Potential adverse events after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling, and possible long term granuloma formation. Intra-arterial administration could result in damage to blood vessels in the distal extremities or organs. To date, Sandoz has not received any adverse event reports or product complaints attributable to particles from any lot of methotrexate, including the lots where flakes have been found.
The following table specifies the products involved in this recall:
Product : Methotrexate Injection, USP, 50-mg/2 mL
NDC Number : 66758-040-02 (10 vial pack) and 66758-040-01 (Individual vial)
|
Lot Number
|
Label Type
|
Exp Date
|
|
92395606
|
Parenta
|
12/2010
|
|
92760803
|
Parenta
|
2/2011
|
|
92965104
|
Parenta
|
3/2011
|
|
92965106
|
Parenta
|
3/2011
|
|
92965904
|
Parenta
|
4/2011
|
|
93255704
|
Parenta
|
6/2011
|
|
93502204
|
Parenta
|
7/2011
|
|
93635404
|
Parenta
|
8/2011
|
|
93681704
|
Parenta
|
8/2011
|
|
93794904
|
Sandoz
|
9/2011
|
|
95198604
|
Sandoz
|
10/2011
|
|
95357804
|
Sandoz
|
12/2011
|
|
95537704
|
Sandoz
|
1/2012
|
|
95987004
|
Sandoz
|
3/2012
|
Product : Methotrexate Injection, USP, 250-mg/10 mL
NDC Number : 66758-040-08 (10 vial pack) and 66758-040-07 (Individual vial)
|
Lot Number
|
Label Type
|
Exp Date
|
|
92395703
|
Parenta
|
12/2010
|
|
92760903
|
Parenta
|
2/2011
|
|
92965203
|
Parenta
|
3/2011
|
|
92966003
|
Parenta
|
4/2011
|
|
93255803
|
Parenta
|
6/2011
|
|
93502303
|
Parenta
|
7/2011
|
|
93635503
|
Parenta
|
8/2011
|
|
93795003
|
Sandoz
|
9/2011
|
|
95198703
|
Sandoz
|
10/2011
|
|
95357903
|
Sandoz
|
12/2011
|
The FDA is advising customers and patients to immediately discontinue use of this product. Patients are being advised to contact their physician if they experience any problem that might be related to the use of this product. Additionally, as noted in the product's labeling, parenteral drug products should be inspected visually for particulate matter and discoloration before administration.
Adverse events related to the use of Sandoz methotrexate products should be reported to Sandoz at 1-800-525-8747 or to the FDA's MedWatch Adverse Event Reporting Program.
圣路易斯(MD Consult)——2010年10月27日，美国食品药品管理局(FDA)宣布，山德士公司开始向美国消费者(使用者)主动召回所有规格为50 mg/2 ml和250 mg/10 ml的山德士及Parenta品牌的瓶装甲氨蝶呤注射液。山德士发现，在该产品的4个批次中有少数药瓶内存在小玻璃碎片。该公司已确定玻璃碎片是由用于生产药瓶的玻璃发生剥脱所产生的。
肠道外注射有问题批次的药物可导致严重的不良事件，并可引起残疾和死亡。另外，鞘膜内给药可引起神经损伤。静脉注射给药后可能发生的不良事件包括肺部血管局部损伤、局限性水肿和肉芽肿形成。肌内给药可引起异物炎症反应，表现为局部疼痛、水肿以及可能有长期肉芽肿形成。动脉内给药可引起肢体远端血管或脏器损伤。迄今，山德士公司尚未收到由任何批次的甲氨蝶呤药瓶中的颗粒引起的任何不良事件报告或产品投诉，包括发现碎片的批次。
下表详细列举了此次召回涉及的药品：
药品名：甲氨蝶呤注射液，USP，50 mg/2 ml
国家药品编码：66758-040-02 (10瓶装) 和 66758-040-01 (单瓶装)
|
Lot Number
|
Label Type
|
Exp Date
|
|
92395606
|
Parenta
|
2010年12月
|
|
92760803
|
Parenta
|
2011年2月
|
|
92965104
|
Parenta
|
2011年3月
|
|
92965106
|
Parenta
|
2011年3月
|
|
92965904
|
Parenta
|
2011年4月
|
|
93255704
|
Parenta
|
2011年6月
|
|
93502204
|
Parenta
|
2011年7月
|
|
93635404
|
Parenta
|
2011年8月
|
|
93681704
|
Parenta
|
2011年8月
|
|
93794904
|
山德士
|
2011年9月
|
|
95198604
|
山德士
|
2011年10月
|
|
95357804
|
山德士
|
2011年12月
|
|
95537704
|
山德士
|
2012年1月
|
|
95987004
|
山德士
|
2012年3月
|
药品名：甲氨蝶呤注射液，USP，250 mg/10 ml
国家药品编码：66758-040-08 (10瓶装) 和66758-040-07 (单瓶装)
|
Lot Number
|
Label Type
|
Exp Date
|
|
92395703
|
Parenta
|
2010年12月
|
|
92760903
|
Parenta
|
2011年2月
|
|
92965203
|
Parenta
|
2011年3月
|
|
92966003
|
Parenta
|
2011年4月
|
|
93255803
|
Parenta
|
2011年6月
|
|
93502303
|
Parenta
|
2011年7月
|
|
93635503
|
Parenta
|
2011年8月
|
|
93795003
|
山德士
|
2011年9月
|
|
95198703
|
山德士
|
2011年10月
|
|
95357903
|
山德士
|
2011年12月
|
FDA目前建议消费者和患者立即停用该产品，同时建议患者在发生任何可能与使用该产品有关的问题时联系其主治医生。另外，正如药品说明书所说，对于肠道外用药在使用前应肉眼检查是否有颗粒物和变色。
使用者应该将与使用山德士甲氨蝶呤药品有关的不良事件通过拨打1-800-525-8747上报至山德士公司或上报至FDA的MedWatch Adverse Event Reporting Program。
