FDA-Drug2022-07-06Class I
Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01
Akcea Therapeutics, Inc.
Hazard
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Sold states
KY, USA
Affected count
450 cartons
Manufactured in
2855 Gazelle Ct, Carlsbad, CA, United States
Products
Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1166-2022Don't want to check this manually?
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