Metformin Hydrochloride Extended-Release (ER) Tablets: Another voluntary recall

On 11-Jun-2020, a nationwide recall of one lot of Metformin Hydrochloride ER Tablets USP, 500 mg [Lot Number: G901203] issued by Lupin Pharmaceuticals, Inc. due to the detection of N-Nitrosodimethylamine (NDMA). Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. NDMA

Voluntary Recall of Metformin Hydrochloride Extended Release Tablets

Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. N‑Nitrosodimethylamine (NDMA) is classified as a probable human carcinogen (a substance with potential to cause cancer) based on results from laboratory tests. With the release of alert of NDMA presence in Metformin

Presence of Nitrosamines (N-Nitrosodimethylamine) in Metformin Extended Release formulations

Metformin is a prescription drug and a first line medication used to control high blood sugar in patients with type 2 diabetes. N-Nitrosodimethylamine is a probable human carcinogen which is not harmful when present within the permitted limits. Exposure to some level of nitrosamines is quite common, as these nitrosamines presence are common in water

Voluntary Nationwide Recall of Finasteride in United States

Finasteride is a 5α-reductase inhibitor used to treat an enlarged prostate (benign prostatic hyperplasia or BPH) or hair loss in men. It is also used to treat excessive hair growth in women and as a part of hormone therapy for transgender women. An independent testing laboratory in the US identified the minoxidil (an antihypertensive drug)

Voluntary Recall of Nizatidine products from US market

Amneal Pharmaceuticals announced recall of nizatidine oral solution, 15 mg/mL, due to presence of potential levels of N-Nitrosodimethylamine (NDMA) impurity, (a probable human carcinogen). Nizatidine is a similar drug to Ranitidine which is commonly used in the treatment of peptic ulcer disease and gastroesophageal reflux disease. It acts as antagonists for histamine (H2) receptor, thereby

Ranitidine drug status in India: Is it still used?

Ranitidine has an Indian market size of Rs 750 crore which is also commonly used OTC and prescription medicine by wide range of patients (pediatrics, adults and the elderly patients) commonly used for intestinal and stomach ulcers, Gastroesophageal Reflux Disease (GERD), esophagitis, Zollinger-Ellison syndrome etc., It is a H-2 blocking agent, which decreases the amount

Drug Recall story of Ranitidine (An established drug since 3 decades)

A medicine having been considered as “Safe” since 1981 is recalled from the drug market. It’s not a surprise on recall of a drug from market which has an “assumed established safety profile”. Ranitidine, popularly known to public as Zantac, is a very common OTC (over the counter) drug and prescription stomach acid blocker widely

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