|
Nitrosamine in Antabuse
|
|
7
|
909
|
April 18, 2023
|
|
Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules due to the presence of a NDSRI, N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level
|
|
5
|
833
|
March 30, 2023
|
|
N-nitroso-propranolol?
|
|
18
|
2238
|
February 22, 2023
|
|
Phathom Pharmaceuticals, Inc received complete response letter from US FDA for its approved Helicobacter pylori drug products due to presence of N-nitroso-vonoprazan (NVP), nitrosamine impurity
|
|
1
|
745
|
February 10, 2023
|
|
N-nitroso-quinapril
|
|
15
|
1795
|
February 1, 2023
|
|
Merck has discovered that nitrosamine NTTP in its blockbuster diabetes medications arose mostly during storage, as well as during manufacturing and believes it can resolve the problem by the end of the year
|
|
6
|
1674
|
January 23, 2023
|
|
New NDSRIs limits coming from EMA soon
|
|
2
|
1961
|
January 16, 2023
|
|
Florida District Court dismissed claims that "Ranitidine-NDMA caused cancer -" because of "unreliable methodologies" and lacked "science-based standards"
|
|
0
|
279
|
December 13, 2022
|
|
Indian Pharmacopoeia Commission (IPC) has introduced new general chapter on (a) "Elemental Impurities" and (b) nitrosamine in Indian Pharmacopoeia (IP) 2022
|
|
4
|
715
|
December 6, 2022
|
|
FDA issued Warning Letter connected to Genetocix Impurities
|
|
0
|
450
|
November 16, 2022
|
|
Health Science Authority Singapore- Update on nitrosamine impurity, Nitroso-STG-19 (also known as NTTP), in sitagliptin products
|
|
2
|
1014
|
November 14, 2022
|
|
Pfizer Japan to Curb Shipments and Recall Amoxapine over Carcinogen Risks
|
|
3
|
568
|
November 10, 2022
|
|
US FDA's 2020 Nitrosamine Guidance may be updated to provide clarity on specific topics, as appropriate (It will be interesting to see if it would include nitrosamine drug substance-related impurities, NDSRIs ? ?)
|
|
0
|
369
|
November 1, 2022
|
|
Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two lots of Quinapril and Hydrochlorothiazide Tablets due to presence of NDSRI, N-Nitroso-Quinapril above the proposed interim limit
|
|
0
|
362
|
October 26, 2022
|
|
Ranitidine brands withdrawn from NLEM in India
|
|
2
|
336
|
September 15, 2022
|
|
Apotex recalls additional Apo-Acyclovir tablets due to a nitrosamine impurity
|
|
5
|
792
|
August 7, 2022
|
|
Strides Pharma and Lupin Pharmaceuticals voluntarily recalled the batches/lots of Losartan Potassium tablets in USA due to AZIDO Impurity levels observed to be above acceptable limits
|
|
0
|
235
|
June 16, 2022
|
|
Stress condition in COC impurity
|
|
6
|
555
|
May 24, 2022
|
|
Sandoz recalls 13 lots of Orphenadrine citrate 100 mg ER tablets
|
|
8
|
689
|
May 3, 2022
|
|
ANVISA finally approved new resolution for conrtol of Nitrosamines in Brazil
|
|
0
|
317
|
April 29, 2022
|
|
Voluntary Recall of lots of ACCUPRIL tablets
|
|
1
|
358
|
April 26, 2022
|
|
Recall of lots of Accuretic tablets by Pfizer
|
|
5
|
558
|
April 25, 2022
|
|
Lupin Pharmaceuticals issues nationwide recall of Irbesartan Tablets
|
|
5
|
679
|
March 22, 2022
|
|
Azithromycin - presence of N-Nitrosamines
|
|
8
|
738
|
March 3, 2022
|
|
Nitrosamines :Authorities Expectations and Typical Mistakes
|
|
0
|
343
|
February 23, 2022
|
|
Nitrosamine impurity in Bumetanide tablets
|
|
2
|
785
|
February 11, 2022
|
|
FDA recommendations for minimisation of Nitrosamine related Imps through formulation design changes
|
|
0
|
237
|
February 9, 2022
|
|
Metformin Recall mktd by Viona Pharmaceuticals Inc
|
|
4
|
313
|
January 20, 2022
|
|
Https://www.fda.gov/media/154487/download
|
|
0
|
229
|
December 8, 2021
|
|
USP- Approved <1469> Nitrosamines Impurities
|
|
1
|
863
|
December 6, 2021
|