FDA Recall D-724-2016
Pharmedium Services, LLC · Lake Forest, IL
Class I — life-threatening Terminated 405 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium
Reason for recall
Subpotent Drug
Recall record
- Recall number
D-724-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.
- Recall initiated
- 2015-01-13
- Classified by FDA Center
- 2016-02-18
- FDA published
- 2016-02-24
- Terminated
- 2016-02-22
- Recalling firm
- Pharmedium Services, LLC
- Firm location
- Lake Forest, IL