fentaNYL Citrate 2,500 mcg/50mL in Sterile Water Recall: Sterility Concern
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN.…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was fentaNYL Citrate 2,500 mcg/50mL in Sterile Water recalled?
Lack of Assurance of Sterility: leaking bags
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
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
Which lot codes, UPCs or models are affected?
Lot#: 20231020FEN-1, Exp: 04/17/2024
- Agency record number
- D-0432-2024
- 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.…
- Recalling firm
- IntegraDose Compounding Services LLC
- Quantity
- 187 cassettes
- Distribution
- Nationwide within the U.S
- Recall started
- March 22, 2024
- Report date
- April 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)