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Class II: temporary or reversible health riskTerminated

PharMEDium Services fentaNYL Citrate Injection 50 mcg per mL Recall

fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Us…

PharMEDium Services, LLC · Dayton, NJ

Risk level
Class II
Reported by FDA
Apr 15, 2020
Recall ID
D-1093-2020
Check your lot numberHow we source this data

Summary

PharMEDium Services recalled fentaNYL Citrate Injection 50 mcg per mL starting Mar 16, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1093-2020 on Apr 15, 2020. Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance. Status: Terminated.

Why it was recalled

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

Product description

fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28

Lot numbers, UPCs & expiration codes

193520008D, Exp 3/18/2020 193540005D, Exp 3/22/2020

Where it was sold

Distributed Nationwide in the US

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-1093-2020
Classification
Class II
Status
Terminated
Recall initiated
Mar 16, 2020
FDA report date
Apr 15, 2020
Quantity
1350 units
Recall type
Voluntary: Firm initiated
Recalling firm
PharMEDium Services, LLC

Original FDA data

Every field from FDA enforcement report D-1093-2020, exactly as published.

Show all FDA fields
City
Dayton
State
NJ
Status
Terminated
Country
United States
Event ID
85212
Address
36 Stults Rd
Code information
193520008D, Exp 3/18/2020 193540005D, Exp 3/22/2020
Postal code
08810
Report date
Apr 15, 2020
Product type
Drugs
Recall number
D-1093-2020
Classification
Class II
Recalling firm
PharMEDium Services, LLC
Product quantity
1350 units
Termination date
Feb 14, 2025
Reason for recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Voluntary / mandated
Voluntary: Firm initiated
Product description
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
Distribution pattern
Distributed Nationwide in the US
Recall initiation date
Mar 16, 2020
Initial firm notification
Letter
Center classification date
Apr 6, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1093-2020, published Apr 15, 2020. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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