FDA警示：Amneal自愿召回尼扎替丁

FDA alerts patients and health care professionals to Amneal’s voluntary recall of nizatidine

FDA警示：Amneal自愿召回尼扎替丁

Update [4/16/2020]

FDA is alerting patients and health care professionals to Amneal Pharmaceutical’s voluntary recall of nizatidine oral solution (15 mg/mL). The medicines are being recalled because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA).

FDA在此警示患者和医护工作者，Amneal正在召回其尼扎替丁口服溶液（15 mg/mL）。本次召回是因为其中可能含有超出可接受水平的NDMA。

FDA has advised companies to recall their nizatidine if testing shows levels of NDMA above the acceptable daily intake limit (96 nanograms per day). The agency posted the results of its testing of nizatidine samples and has asked companies to conduct their own laboratory testing.

FDA已建议检测发现其药品中NDMA超出可接受口摄入限度（96μg/天）的公司召回其尼扎替丁药品。FDA已发布了对尼扎替丁样品检测的结果，并且要求公司在自己实验室进行检测。

Patients taking prescription nizatidine who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as nizatidine.

正在使用处方尼扎替丁药品的患者如果希望停止使用，应与其医护人员讨论其它治疗选择。目前有多种已批准药品可用于尼扎替丁的相同或类似用途。

Company 公司

Product 药品

Lots  Tested 所测批次

NDMA level  ppm

NDMA level  (micrograms-mcg/tablet or oral dose)

NDMA水平(μg/片或口服剂量)

Sanofi Pharmaceutical

OTC Ranitidine 150mg

19E413M, 19D554, 19A432U, 19C540, 19D431I,  19D442N, 19D423M, 19D464M,

0.07-2.38

0.01-0.36

Sanofi Pharmaceutical

OTC Ranitidine 75mg

18L012U, 9A003U, 19B006M, 18M025M, 18N023U,  19B005N, 19A002U, 18N026U

0.10-0.55

0.01-0.04

Cardinal Health

OTC Ranitidine 150mg

9FE2953

1.02

0.15

Watson

Rx Nizatidine 150mg

1350798M

0.05

0.01

Watson

Rx Nizatidine 300mg

1333973A

0.04

0.01

Strides Shasun Ltd

Rx Nizatidine 150mg

7704758A

0.11

0.02

Strides Shasun Ltd

Rx Nizatidine 300mg

7704022A

0.09

0.03

Novitium

Rx Ranitidine 300mg

S18038B

2.85

0.86

Dr Reddy's

Rx Ranitidine 300mg

C805265

0.68

0.20

Strides Shasun Ltd

Rx Ranitidine 300mg

7702255A

0.11

0.03

Sandoz

Rx Ranitidine 300mg

HU2207

0.82

0.25

Strides Shasun Ltd

Rx Ranitidine 300mg

7704537A

0.02

0.00

Aurobindo

Rx Ranitidine 300mg

RA3019001-A

1.86

0.56

Ajanta Pharma USA Inc

Rx Ranitidine 300mg

PA1229B

0.23

0.07

Silarx Pharma

Ranitidine 150mg Syrup

3652081-02661

1.37

0.20

Pharma Associates

Ranitidine 150mg Syrup

BE00, BF75, BF77, BF78, BDFF, COAC

0.03-0.07

0.004-0.012

Amneal Pharmaceuticals

Ranitidine 300mg

AR181795A, AR190878A, AR190876A, AR191177A,  HB05819, HB06119, HL08718

0.52-2.17

0.16-0.65

Sanofi Pharmaceutical

Ranitidine 150mg

19D570, 19D428U, 19E408M

0.08-2.17

0.01-0.33