Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each
Summary
The FDA issued a Class I for Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcu by Akcea Therapeutics, Inc.. Reason: Superpotent: High Out of specification (OOS) test result for percent label claim (%LC)..
Details
Source
Drug Recall
External ID
D-1166-2022
Action Date
2022-07-06
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lots: 028C21AB, 028C21AC, Exp. 05/2025
Quantity Affected: 450 cartons
Reason for Recall
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Distribution
KY, USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-23
Company
Carlsbad, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 29 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Akcea Therapeutics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Akcea Therapeutics, Inc. have FDA actions?
This is the only FDA action we have on record for Akcea Therapeutics, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1166-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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