Tegsedi Injection Recalled for Higher-Than-Labeled Content
Akcea Therapeutics recalls certain Tegsedi (inotersen) Injection lots due to higher-than-labeled active ingredient content. Affected lots were distributed in Kentucky.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4. The product contains higher potency than labeled, creating a potential overdose risk with an injectable prescription medication. No reported illnesses or deaths are documented in the source material.
Plain-English summary
Akcea Therapeutics, Inc. is recalling specific lots of Tegsedi (inotersen) Injection 284 mg/1.5 mL due to out-of-specification test results for the percent label claim. Testing identified that the affected product is superpotent, containing more active ingredient than stated on the label.
The affected lots are 028C21AB and 028C21AC, with expiration date 05/2025, distributed in Kentucky. A total of 450 cartons of the 4-syringe package (NDC 72126-007-01) are affected.
Tegsedi is a prescription injectable medication used to treat transthyretin amyloidosis. Patients and healthcare providers who have this medication should consult their healthcare provider immediately. Do not use affected lots. Contact Sobi, Inc. or Akcea Therapeutics for return instructions.
The recalled product
- Product
- 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
- Manufacturer
- Akcea Therapeutics, Inc.
- Category
- Drug — Injectable
- Hazard
- potency-deviation
- overdose-risk
- label-accuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots: 028C21AB
- 028C21AC
- Exp. 05/2025
Distribution
Distributed in 1 state:
- KY
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