Reported Jul 6, 2022 · Terminated
Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each…
Akcea Therapeutics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akcea Therapeutics, Inc. · 2855 Gazelle Ct · Carlsbad, CA · 92010-6670
Is this the product you have?
- 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
- NDC72126-007-01
- Lot codes and dates
- Lots
028C21AB028C21ACExp. 05/2025
- Lots
- Amount recalled
- 450 cartons
Where it was sold
Why it was recalled
Stop using this product now
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Using this product could cause serious injury, illness or death — stop using it now.
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