Medicine recalls
|
| |
| The United States: Ascend Laboratories LLC. issues voluntary nationwide recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg |
| |
The US Food and Drug Administration (FDA) announces that Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etexilate Capsules, USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine, N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. The affected products are:
- Dabigatran Etexilate Mesylate Caps 75 mg (lot number: 22142462, 22142463, 22142464, 22143000, 22143001, 22143002)
- Dabigatran Etexilate Mesylate Caps 150 mg (lot number: 22142448, 22142449, 22142450, 22143845)
To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ascend-laboratories-llc-issues-voluntary-nationwide-recall-dabigatran-etexilate-capsules-usp-75-mg
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Mar 23, 2023
Issued at HKT 14:00
|
| |
