WebMay 22, 2024 · On March 21, 2024, Sandoz issued a voluntary recall of 13 lots of the drug orphenadrine citrate 100mg ER tablets due to the presence of nitrosamine. … WebMar 11, 2024 · A product recall is the outcome of a careful pharmacovigilance; and it is an integral part of drug regulation. Among various reasons for product recall, the detection of unacceptable levels of carcinogenic impurities is one of the most serious concerns. The genotoxic and carcinogenic potential of N-nitrosamines raises a serious safety concern, …
DailyMed - ORPHENADRINE CITRATE tablet
WebFeb 28, 2024 · Orphenadrine may be habit-forming. Never share orphenadrine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law. Orphenadrine is usually taken 2 times per day, once in the morning and … WebMar 23, 2024 · Mar 23, 2024 2:16AM EDT. (RTTNews) - Sandoz Inc., a generic and biosimilar medicines unit of French drug major Novartis, is recalling 13 lots of oral pain management drug Orphenadrine Citrate 100 ... the gtg
Orphenadrine Side Effects, Dosage, Uses, and More - Healthline
WebMay 5, 2024 · Update [9/17/2024] FDA is alerting patients and health care professionals that Pfizer is expanding its voluntary recall to include all lots of varenicline (Chantix) 0.5 mg and 1 mg tablets. Pfizer ... WebMar 22, 2024 · Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity. March … WebDrug recall notice for Orphenadrine Citrate 100 mg (ER) tablets Princeton, NJ, Sandoz Inc. voluntarily recalled 13 lots of oral Orphenadrine Citrate 100 mg Extended Release (ER) tablets due to the presence of a nitrosamine impurity, which may cause cancer in amounts above acceptable levels that was detected in the lots during testing. the gt guys