D-1393-2016 Class II Terminated
FDA drug recall D-1393-2016 was initiated by Pharmedium Services, LLC on May 5, 2016 and is designated Class II. Reason for recall: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. The recall status is terminated (terminated Mar 6, 2018). Affected quantity: 1,476 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 27, 2016
- Initiation Date
- May 5, 2016
- Termination Date
- Mar 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,476 bags
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 ,
Reason for Recall
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Distribution Pattern
Nationwide
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 ;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1393-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026