FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

OurPharma FentaNYL Citrate 2 Recall

FentaNYL Citrate 2

OurPharma LLC · Fayetteville, AR

Risk level
Class II
Reported by FDA
Dec 21, 2022
Recall ID
D-0078-2023
Check your lot numberHow we source this data

Summary

OurPharma recalled FentaNYL Citrate 2 starting Nov 29, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0078-2023 on Dec 21, 2022. Reason: Underfilled units. Status: Terminated.

Why it was recalled

Underfilled units.

Product description

FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01

Lot numbers, UPCs & expiration codes

Lots: 100122060007 Exp. 12/17/2022; 100122060008 Exp. 12/18/2022; 100122070002 Exp. 01/09/2023.

Where it was sold

MO

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-0078-2023
Classification
Class II
Status
Terminated
Recall initiated
Nov 29, 2022
FDA report date
Dec 21, 2022
Quantity
691 cassettes
Recall type
Voluntary: Firm initiated
Recalling firm
OurPharma LLC

Original FDA data

Every field from FDA enforcement report D-0078-2023, exactly as published.

Show all FDA fields
City
Fayetteville
State
AR
Status
Terminated
Country
United States
Event ID
91229
Address
2512 S City Lake Rd
Code information
Lots: 100122060007 Exp. 12/17/2022; 100122060008 Exp. 12/18/2022; 100122070002 Exp. 01/09/2023.
Postal code
72701-5013
Report date
Dec 21, 2022
Product type
Drugs
Recall number
D-0078-2023
Classification
Class II
Recalling firm
OurPharma LLC
Product quantity
691 cassettes
Termination date
Sep 20, 2024
Reason for recall
Underfilled units.
Voluntary / mandated
Voluntary: Firm initiated
Product description
FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01
Distribution pattern
MO
Recall initiation date
Nov 29, 2022
Initial firm notification
Letter
Center classification date
Dec 9, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0078-2023, published Dec 21, 2022. 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls