Nitrosamines in the News

Topic	Replies	Views	Activity
About the Nitrosamines in the News category	0	95	April 14, 2021
Ministry of Food and Drug Safety of the Republic of Korea detected N-Nitroso-Atenolol in atenolol formulation products	5	362	May 7, 2023
Phathom Pharmaceuticals reported that it has detected trace levels of a nitrosamine impurity in their vonoprazan-based products (may be NDSRI, nitroso-Vonoprazan ? ) that is not described within the FDA Nitrosamine guidance document	14	647	April 27, 2023
The Great Nitrosamine Audit: how many more drugs will disappear from our shelves?	2	342	April 26, 2023
Nitrosamine in Antabuse	7	329	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 NDSRI	5	415	March 30, 2023
ISP (Chile) announced the voluntary market withdrawal of Atomoxetine DP (40mg & 80mg) due presence of Nitroso-Atomoxetine	3	276	March 1, 2023
Apotex Inc. Canada is recalling one lot of APO-Amitriptyline due to presence of nitrosamine impurity, N-nitrosodimethylamine (NDMA) above the acceptable limit at the 48-month stability testing timepoint	7	313	February 27, 2023
N-nitroso-propranolol?	18	984	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	326	February 10, 2023
N-nitroso-quinapril	15	836	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	556	January 23, 2023
New NDSRIs limits coming from EMA soon	2	709	January 16, 2023
Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of new paragraph on control of N-nitrosamines	0	232	January 15, 2023
Florida District Court dismissed claims that "Ranitidine-NDMA caused cancer -" because of "unreliable methodologies" and lacked "science-based standards" FDA	0	94	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	263	December 6, 2022
FDA issued Warning Letter connected to Genetocix Impurities	0	197	November 16, 2022
Health Science Authority Singapore- Update on nitrosamine impurity, Nitroso-STG-19 (also known as NTTP), in sitagliptin products	2	255	November 14, 2022
Pfizer Japan to Curb Shipments and Recall Amoxapine over Carcinogen Risks NDSRI	3	253	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	201	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	172	October 26, 2022
Ranitidine brands withdrawn from NLEM in India	2	113	September 15, 2022
Apotex recalls additional Apo-Acyclovir tablets due to a nitrosamine impurity	5	244	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	115	June 16, 2022
Stress condition in COC impurity Storage_Stability	6	199	May 24, 2022
Sandoz recalls 13 lots of Orphenadrine citrate 100 mg ER tablets	8	246	May 3, 2022
ANVISA finally approved new resolution for conrtol of Nitrosamines in Brazil	0	144	April 29, 2022
Voluntary Recall of lots of ACCUPRIL tablets	1	131	April 26, 2022
Recall of lots of Accuretic tablets by Pfizer	5	256	April 25, 2022
Lupin Pharmaceuticals issues nationwide recall of Irbesartan Tablets	5	249	March 22, 2022