FDA Drugs recall ·
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII… recall
- Recall number
- D-0225-2025
- Date
- (initiated January 31, 2025)
- Company / brand
- Fagron Compounding Services
8710 E 34th St N, Wichita, KS, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 1330 bags
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # C274-000040409, Exp 03/22/2025
Distribution
Distributed in PA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0225-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.