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 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.
Lot numbers, UPCs & expiration codes
Lot Numbers: 151000045M, 15127040M, 15133026M, 15141029M, 151930078M, 15132103M, 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-0032-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 17, 2015
- FDA report date
- Oct 19, 2016
- Quantity
- 210 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0032-2017, 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: 151000045M, 15127040M, 15133026M, 15141029M, 151930078M, 15132103M, Exp between 07/15/15-10/12/15
- Postal code
- 60045-2506
- Report date
- Oct 19, 2016
- Product type
- Drugs
- Recall number
- D-0032-2017
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 210 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 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 17, 2015
- Initial firm notification
- Center classification date
- Oct 12, 2016