FDA Drug Recalls

Recalls / Class II

Class IID-0037-2017

Product

fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3303.

Affected lot / code info
Lot Numbers: 15119083M, 15119086M, 15133078M, 15134127M, 15135064M, 151380066M, 15138007M, 151380108M, 151380109M, 15138060M, 15138063M, 15138064M, 15138065M, 15140043M, 15140082M, 15140084M, 15142093M, 151450033M, 151460093M, 151460094M, 15147097M, 15149047M, 15149108M, 15149112M, 15149113M, 15152051M, 15152053M, 15160010C, 15161003C, 15161004C, 15161007C, 15161008C, 15163003C, 151650036C, 151660042C, 151660043C, 151670006C, 151670007C, 151670008C, 151680044C, 151720006C, 151720013M, 151720106M, 151730140M, 151730141M, 151730143M, 151740003C, 151740004C, 151740137M, 151750008C, 151760042C, 151790004C, 151790040C, 151880332M, 151890122M, 151890123M, 151900009M, 151900137M, 151900178M, 151900243M, 151930033M, 15100140M, 151020015M, 151020016M, 15103004M, 151030057M, 151030092M, 151170046M, 151170087M, 151170088M, 151170089M, 15120066M, 15120068M, 15124083M, 151260091M, 15127016M, 15127089M, 15127092M, 15127093M, 15128108M, 15128109M, 151310088M, 151310089M, 151310101M, 151310102M, 151310104M, 15132007C, 151320098M, 15133003C, 15133013C, 15135011C, 15138006C, 15139012C, 15141001C, 15142004C, 15142005C, 15147001C, 15147002C, 15147003C, 15147004C, 15147013C, 15147014C, 15149005C, 15152009C, 15154007C, 15155001C, 15155009C, 15156004C, 15157003C, 15159004C, Exp between 07/15/15-10/12/15

Why it was recalled

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Recalling firm

Firm
Pharmedium Services, LLC
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506

Distribution

Quantity
53357 syringes
Distribution pattern
Nationwide

Timeline

Recall initiated
2015-07-17
FDA classified
2016-10-12
Posted by FDA
2016-10-19
Terminated
2017-06-23
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0037-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.