fentaNYL Citrate 2 recall
FDA recall D-0432-2024 · initiated Mar 22, 2024
IntegraDose Compounding Services LLC recalled fentaNYL Citrate 2 in Mar 2024 — an FDA Class II recall (D-0432-2024) because Lack of Assurance of Sterility: leaking bags.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: leaking bags
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 187 cassettes
Details
- Product
- fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
- Recalling company
- IntegraDose Compounding Services LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the U.S
- Initiated
- Mar 22, 2024
- FDA report date
- Apr 10, 2024
Frequently asked
- Was fentaNYL Citrate 2 recalled?
- IntegraDose Compounding Services LLC recalled fentaNYL Citrate 2 in Mar 2024 — an FDA Class II recall (D-0432-2024) because Lack of Assurance of Sterility: leaking bags. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was fentaNYL Citrate 2 recalled?
- Per the FDA enforcement record, the reason for recall D-0432-2024 was: Lack of Assurance of Sterility: leaking bags
- Is a recalled fentaNYL Citrate 2 dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of fentaNYL Citrate 2 are affected?
- Distributed: Nationwide within the U.S. The recall covers these lots — Lot#: 20231020FEN-1, Exp: 04/17/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0432-2024.