Home / Recalls / Pharmedium Services, LLC / D-1375-2016

D-1375-2016 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-1375-2016 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: 1,527 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: 1,527 bags

Product Description

1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95

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 2K9998 , Lot Number 160460135M , Exp. Date 5/10/2016 ; Service Code 2K9998 , Lot Number 160530146M , Exp. Date 5/17/2016 ; Service Code 2K9998 , Lot Number 160590137M , Exp. Date 5/23/2016 ; Service Code 2K9998 , Lot Number 160660221M , Exp. Date 5/30/2016 ; Service Code 2K9998 , Lot Number 160730163M , Exp. Date 6/6/2016 ; Service Code 2K9998 , Lot Number 160870147M , Exp. Date 6/20/2016 ; Service Code 2K9998 , Lot Number 160880265M , Exp. Date 6/21/2016 ; Service Code 2K9998 , Lot Number 160940206M , Exp. Date 6/27/2016 ; Service Code 2K9998 , Lot Number 161080210M , Exp. Date 7/11/2016 ; Service Code 2T8998 , Lot Number 160460267M , Exp. Date 5/7/2016 ; Service Code 2T8998 , Lot Number 160470042M , Exp. Date 5/8/2016 ; Service Code 2T8998 , Lot Number 160530034M , Exp. Date 5/14/2016 ; Service Code 2T8998 , Lot Number 160610043M , Exp. Date 5/22/2016 ; Service Code 2T8998 , Lot Number 160640008M , Exp. Date 5/24/2016 ; Service Code 2T8998 , Lot Number 160690011C , Exp. Date 5/30/2016 ; Service Code 2T8998 , Lot Number 160690012C , Exp. Date 5/30/2016 ; Service Code 2T8998 , Lot Number 160740064C , Exp. Date 6/4/2016 ; Service Code 2T8998 , Lot Number 160810066C , Exp. Date 6/11/2016 ; Service Code 2T8998 , Lot Number 160840030C , Exp. Date 6/14/2016 ; Service Code 2T8998 , Lot Number 160880042C , Exp. Date 6/18/2016 ; Service Code 2T8998 , Lot Number 160880043C , Exp. Date 6/18/2016 ; Service Code 2T8998 , Lot Number 160910014C , Exp. Date 6/21/2016 ; Service Code 2T8998 , Lot Number 160910015C , Exp. Date 6/21/2016 ; Service Code 2T8998 , Lot Number 160950071C , Exp. Date 6/25/2016 ;

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1375-2016
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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