Why it was recalled
Short Fill: Underfilled units.
Product description
FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01.
Lot numbers, UPCs & expiration codes
Lots: 100122080003, Exp. 2/26/2023; 100122090001, Exp. 3/07/2023; 100122100002, Exp. 4/05/2023
Where it was sold
IL and 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-0172-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 13, 2023
- FDA report date
- Feb 1, 2023
- Quantity
- 768 cassettes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- OurPharma LLC
Original FDA data
Every field from FDA enforcement report D-0172-2023, exactly as published.
Show all FDA fields
- City
- Fayetteville
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 91520
- Address
- 2512 S City Lake Rd
- Code information
- Lots: 100122080003, Exp. 2/26/2023; 100122090001, Exp. 3/07/2023; 100122100002, Exp. 4/05/2023
- Postal code
- 72701-5013
- Report date
- Feb 1, 2023
- Product type
- Drugs
- Recall number
- D-0172-2023
- Classification
- Class III
- Recalling firm
- OurPharma LLC
- Product quantity
- 768 cassettes
- Termination date
- Sep 20, 2024
- Reason for recall
- Short Fill: Underfilled units.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01.
- Distribution pattern
- IL and MO
- Recall initiation date
- Jan 13, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 23, 2023