Why it was recalled
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Product description
2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8296 (NDC 61553-296-52), 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8296 (NDC 61553-296-22), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,
Lot numbers, UPCs & expiration codes
Service Code 2H8296 , Lot Number 160420192M , Exp. Date 5/8/2016 ; Service Code 2H8296 , Lot Number 160450199M , Exp. Date 5/11/2016 ; Service Code 2H8296 , Lot Number 160490146M , Exp. Date 5/15/2016 ; Service Code 2H8296 , Lot Number 160590180M , Exp. Date 5/25/2016 ; Service Code 2H8296 , Lot Number 160660231M , Exp. Date 6/1/2016 ; Service Code 2H8296 , Lot Number 160700136M , Exp. Date 6/5/2016 ; Service Code 2H8296 , Lot Number 160770233M , Exp. Date 6/12/2016 ; Service Code 2H8296 , Lot Number 160820140M , Exp. Date 6/17/2016 ; Service Code 2H8296 , Lot Number 160880282M , Exp. Date 6/23/2016 ; Service Code 2H8296 , Lot Number 160910131M , Exp. Date 6/26/2016 ; Service Code 2H8296 , Lot Number 160970117M , Exp. Date 7/1/2016 ; Service Code 2H8296 , Lot Number 161080157M , Exp. Date 7/13/2016 ; Service Code 2K8296 , Lot Number 160420191M , Exp. Date 5/12/2016 ; Service Code 2K8296 , Lot Number 160480230M , Exp. Date 5/18/2016 ; Service Code 2K8296 , Lot Number 160540227M , Exp. Date 5/24/2016 ; Service Code 2K8296 , Lot Number 160610205M , Exp. Date 5/31/2016 ; Service Code 2K8296 , Lot Number 160670249M , Exp. Date 6/6/2016 ; Service Code 2K8296 , Lot Number 160830181M , Exp. Date 6/22/2016 ; Service Code 2K8296 , Lot Number 160840213M , Exp. Date 6/23/2016 ; Service Code 2T6296 , Lot Number 160450196M , Exp. Date 5/15/2016 ; Service Code 2T6296 , Lot Number 160530159M , Exp. Date 5/23/2016 ; Service Code 2T6296 , Lot Number 160690195M , Exp. Date 6/8/2016 ; Service Code 2T6296 , Lot Number 160750219M , Exp. Date 6/14/2016 ; Service Code 2T6296 , Lot Number 160810166M , Exp. Date 6/20/2016 ; Service Code 2T6296 , Lot Number 160880176M , Exp. Date 6/26/2016 ; Service Code 2T6296 , Lot Number 160940048M , Exp. Date 7/2/2016 ; Service Code 2T6296 , Lot Number 160970123M , Exp. Date 7/5/2016 ;
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-1393-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 5, 2016
- FDA report date
- Jul 27, 2016
- Quantity
- 1,476 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-1393-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 74057
- Address
- 150 N Field Dr Ste 350
- Code information
- Service Code 2H8296 , Lot Number 160420192M , Exp. Date 5/8/2016 ; Service Code 2H8296 , Lot Number 160450199M , Exp. Date 5/11/2016 ; Service Code 2H8296 , Lot Number 160490146M , Exp. Date 5/15/2016 ; Service Code 2H8296 , Lot Number 160590180M , Exp. Date 5/25/2016 ; Service Code 2H8296 , Lot Number 160660231M , Exp. Date 6/1/2016 ; Service Code 2H8296 , Lot Number 160700136M , Exp. Date 6/5/2016 ; Service Code 2H8296 , Lot Number 160770233M , Exp. Date 6/12/2016 ; Service Code 2H8296 , Lot Number 160820140M , Exp. Date 6/17/2016 ; Service Code 2H8296 , Lot Number 160880282M , Exp. Date 6/23/2016 ; Service Code 2H8296 , Lot Number 160910131M , Exp. Date 6/26/2016 ; Service Code 2H8296 , Lot Number 160970117M , Exp. Date 7/1/2016 ; Service Code 2H8296 , Lot Number 161080157M , Exp. Date 7/13/2016 ; Service Code 2K8296 , Lot Number 160420191M , Exp. Date 5/12/2016 ; Service Code 2K8296 , Lot Number 160480230M , Exp. Date 5/18/2016 ; Service Code 2K8296 , Lot Number 160540227M , Exp. Date 5/24/2016 ; Service Code 2K8296 , Lot Number 160610205M , Exp. Date 5/31/2016 ; Service Code 2K8296 , Lot Number 160670249M , Exp. Date 6/6/2016 ; Service Code 2K8296 , Lot Number 160830181M , Exp. Date 6/22/2016 ; Service Code 2K8296 , Lot Number 160840213M , Exp. Date 6/23/2016 ; Service Code 2T6296 , Lot Number 160450196M , Exp. Date 5/15/2016 ; Service Code 2T6296 , Lot Number 160530159M , Exp. Date 5/23/2016 ; Service Code 2T6296 , Lot Number 160690195M , Exp. Date 6/8/2016 ; Service Code 2T6296 , Lot Number 160750219M , Exp. Date 6/14/2016 ; Service Code 2T6296 , Lot Number 160810166M , Exp. Date 6/20/2016 ; Service Code 2T6296 , Lot Number 160880176M , Exp. Date 6/26/2016 ; Service Code 2T6296 , Lot Number 160940048M , Exp. Date 7/2/2016 ; Service Code 2T6296 , Lot Number 160970123M , Exp. Date 7/5/2016 ;
- Postal code
- 60045-2506
- Report date
- Jul 27, 2016
- Product type
- Drugs
- Recall number
- D-1393-2016
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 1,476 bags
- Termination date
- Mar 6, 2018
- Reason for recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8296 (NDC 61553-296-52), 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8296 (NDC 61553-296-22), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,
- Distribution pattern
- Nationwide
- Recall initiation date
- May 5, 2016
- Initial firm notification
- Center classification date
- Jul 16, 2016