Why it was recalled
Subpotent Drug
Product description
fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.
Lot numbers, UPCs & expiration codes
Lot #: 15002077M, Exp 04-02-2015
Where it was sold
Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.
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-723-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 13, 2015
- FDA report date
- Feb 24, 2016
- Quantity
- 180 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-723-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 72380
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot #: 15002077M, Exp 04-02-2015
- Postal code
- 60045-2506
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-723-2016
- Classification
- Class I
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 180 syringes
- Termination date
- Feb 22, 2016
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.
- Distribution pattern
- Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.
- Recall initiation date
- Jan 13, 2015
- Initial firm notification
- Telephone
- Center classification date
- Feb 18, 2016