Class III · Low risk
Prochlorperazine Maleate Tablets
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Tegsedi (inotersen)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDC
72126-0007-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Akcea Therapeutics, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1166-2022 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other wrong potency / content recalls from 2022
All wrong potency / content recalls
Class II · Moderate risk
Desmopressin Acetate Tablet
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Class II · Moderate risk
Desmopressin Acetate Tablets 0.2mg
Subpotent Drug
Class II · Moderate risk
Sensorcaine-MPF
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
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