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Class II: temporary or reversible health riskTerminated

Pharmedium Services fentaNYL Citrate Injection Recall

fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a sy…

Pharmedium Services, LLC · Lake Forest, IL

Risk level
Class II
Reported by FDA
Oct 19, 2016
Recall ID
D-0037-2017
Check your lot numberHow we source this data

Summary

Pharmedium Services recalled fentaNYL Citrate Injection starting Jul 17, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0037-2017 on Oct 19, 2016. Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Status: Terminated.

Why it was recalled

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

Product description

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.

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0037-2017
Classification
Class II
Status
Terminated
Recall initiated
Jul 17, 2015
FDA report date
Oct 19, 2016
Quantity
53357 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Pharmedium Services, LLC

Original FDA data

Every field from FDA enforcement report D-0037-2017, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
73925
Address
150 N Field Dr Ste 350
Code information
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
Postal code
60045-2506
Report date
Oct 19, 2016
Product type
Drugs
Recall number
D-0037-2017
Classification
Class II
Recalling firm
Pharmedium Services, LLC
Product quantity
53357 syringes
Termination date
Jun 23, 2017
Reason for recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
Nationwide
Recall initiation date
Jul 17, 2015
Initial firm notification
E-Mail
Center classification date
Oct 12, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0037-2017, published Oct 19, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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