D-1420-2016 Class II Terminated
FDA drug recall D-1420-2016 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: 936 Medical Cassettes.
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
- 936 Medical Cassettes
Product Description
4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop, free-flow protection, Service Code 2T8214, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-214-48
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 2K8130 , Lot Number 160450167M , Exp. Date 5/9/2016 ; Service Code 2K8130 , Lot Number 160460113M , Exp. Date 5/10/2016 ; Service Code 2K8130 , Lot Number 160490184M , Exp. Date 5/13/2016 ; Service Code 2K8130 , Lot Number 160540122M , Exp. Date 5/17/2016 ; Service Code 2K8130 , Lot Number 160590163M , Exp. Date 5/23/2016 ; Service Code 2K8130 , Lot Number 160610226M , Exp. Date 5/25/2016 ; Service Code 2K8130 , Lot Number 160630185M , Exp. Date 5/27/2016 ; Service Code 2K8130 , Lot Number 160670242M , Exp. Date 5/31/2016 ; Service Code 2K8130 , Lot Number 160680239M , Exp. Date 6/1/2016 ; Service Code 2K8130 , Lot Number 160730147M , Exp. Date 6/6/2016 ; Service Code 2K8130 , Lot Number 160750140M , Exp. Date 6/8/2016 ; Service Code 2K8130 , Lot Number 160770169M , Exp. Date 6/10/2016 ; Service Code 2K8130 , Lot Number 160820223M , Exp. Date 6/15/2016 ; Service Code 2K8130 , Lot Number 160840161M , Exp. Date 6/17/2016 ; Service Code 2K8130 , Lot Number 160850004M , Exp. Date 6/17/2016 ; Service Code 2K8130 , Lot Number 160960163M , Exp. Date 6/29/2016 ; Service Code 2K8214 , Lot Number 160480213M , Exp. Date 5/18/2016 ; Service Code 2K8214 , Lot Number 160490043C , Exp. Date 5/19/2016 ; Service Code 2K8214 , Lot Number 160660037M , Exp. Date 6/4/2016 ; Service Code 2K8214 , Lot Number 160680039M , Exp. Date 6/6/2016 ; Service Code 2K8214 , Lot Number 160700003M , Exp. Date 6/8/2016 ; Service Code 2K8214 , Lot Number 160770051M , Exp. Date 6/15/2016 ; Service Code 2K8214 , Lot Number 160840167M , Exp. Date 6/23/2016 ; Service Code 2K8214 , Lot Number 160900176M , Exp. Date 6/29/2016 ; Service Code 2K9130 , Lot Number 160470154M , Exp. Date 5/17/2016 ; Service Code 2K9130 , Lot Number 160520171M , Exp. Date 5/22/2016 ; Service Code 2K9130 , Lot Number 160670175M , Exp. Date 6/6/2016 ; Service Code 2K9130 , Lot Number 160870068M , Exp. Date 6/25/2016 ; Service Code 2T8214 , Lot Number 160480151M , Exp. Date 5/9/2016 ; Service Code 2T8214 , Lot Number 160490007M , Exp. Date 5/9/2016 ; Service Code 2T8214 , Lot Number 160550162M , Exp. Date 5/16/2016 ; Service Code 2T8214 , Lot Number 160560003M , Exp. Date 5/16/2016 ; Service Code 2T8214 , Lot Number 160600198M , Exp. Date 5/21/2016 ; Service Code 2T8214 , Lot Number 160610004M , Exp. Date 5/21/2016 ; Service Code 2T8214 , Lot Number 160680166M , Exp. Date 5/29/2016 ; Service Code 2T8214 , Lot Number 160740177M , Exp. Date 6/4/2016 ; Service Code 2T8214 , Lot Number 160810191M , Exp. Date 6/11/2016 ; Service Code 2T8214 , Lot Number 160880179M , Exp. Date 6/17/2016 ; Service Code 2T8214 , Lot Number 160910133M , Exp. Date 6/21/2016 ; Service Code 2T8214 , Lot Number 160960150M , Exp. Date 6/26/2016 ;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1420-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026