FDA-Drug2023-04-05Class II
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.
Ascend Laboratories, LLC
Hazard
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Sold states
Nationwide in the USA.
Affected count
12,804 bottles
Manufactured in
339 Jefferson Rd Ste 101, N/A, Parsippany, NJ, United States
Products
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0534-2023Don't want to check this manually?
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