D-1419-2016 Class II Terminated
FDA drug recall D-1419-2016 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: 3,828 syringes.
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
- 3,828 syringes
Product Description
4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
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 2H8267 , Lot Number 160630024M , Exp. Date 5/28/2016 ; Service Code 2K8128 , Lot Number 160490252M , Exp. Date 5/13/2016 ; Service Code 2K8128 , Lot Number 160530274M , Exp. Date 5/17/2016 ; Service Code 2K8128 , Lot Number 160600213M , Exp. Date 5/24/2016 ; Service Code 2K8128 , Lot Number 160660184M , Exp. Date 5/30/2016 ; Service Code 2K8128 , Lot Number 160730236M , Exp. Date 6/6/2016 ; Service Code 2K8128 , Lot Number 160810218M , Exp. Date 6/14/2016 ; Service Code 2K8128 , Lot Number 160820186M , Exp. Date 6/15/2016 ; Service Code 2K8128 , Lot Number 160940172M , Exp. Date 6/27/2016 ; Service Code 2K8267 , Lot Number 160450259M , Exp. Date 5/15/2016 ; Service Code 2K8267 , Lot Number 160540156M , Exp. Date 5/24/2016 ; Service Code 2K8267 , Lot Number 160600323M , Exp. Date 5/30/2016 ; Service Code 2K8267 , Lot Number 160660257M , Exp. Date 6/5/2016 ; Service Code 2K8267 , Lot Number 160730258M , Exp. Date 6/12/2016 ; Service Code 2K8267 , Lot Number 160770130M , Exp. Date 6/16/2016 ; Service Code 2K8267 , Lot Number 160840132M , Exp. Date 6/23/2016 ; Service Code 2K8267 , Lot Number 160900007M , Exp. Date 6/28/2016 ; Service Code 2K8267 , Lot Number 160970143M , Exp. Date 7/6/2016 ; Service Code 2K8267 , Lot Number 161080249M , Exp. Date 7/17/2016 ; Service Code 2K8638 , Lot Number 160410229M , Exp. Date 5/11/2016 ; Service Code 2K8638 , Lot Number 160420200M , Exp. Date 5/12/2016 ; Service Code 2K8638 , Lot Number 160460214M , Exp. Date 5/16/2016 ; Service Code 2K8638 , Lot Number 160480210M , Exp. Date 5/17/2016 ; Service Code 2K8638 , Lot Number 160490254M , Exp. Date 5/19/2016 ; Service Code 2K8638 , Lot Number 160490255M , Exp. Date 5/19/2016 ; Service Code 2K8638 , Lot Number 160520127M , Exp. Date 5/22/2016 ; Service Code 2K8638 , Lot Number 160600310M , Exp. Date 5/30/2016 ; Service Code 2K8638 , Lot Number 160630164M , Exp. Date 6/2/2016 ; Service Code 2K8638 , Lot Number 160670272M , Exp. Date 6/6/2016 ; Service Code 2K8638 , Lot Number 160750259M , Exp. Date 6/14/2016 ; Service Code 2K8638 , Lot Number 160770264M , Exp. Date 6/16/2016 ; Service Code 2K8638 , Lot Number 160840238M , Exp. Date 6/23/2016 ; Service Code 2K8638 , Lot Number 160870197M , Exp. Date 6/26/2016 ; Service Code 2K8638 , Lot Number 160950189M , Exp. Date 7/4/2016 ; Service Code 2K8983 , Lot Number 160530047C , Exp. Date 5/14/2016 ; Service Code 2K8983 , Lot Number 160740088C , Exp. Date 6/4/2016 ; Service Code 2K8983 , Lot Number 160880066C , Exp. Date 6/18/2016 ; Service Code 2K8983 , Lot Number 160970040C , Exp. Date 6/27/2016 ;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1419-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026