2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free)
Medicine recall D-1396-2016. Published in FDA’s Enforcement Report on Jul 27, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 27, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 97,716 bags how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag ; Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8205 , NDC 61553-205-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8104 , NDC 61553-104-03 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K8124 , NDC 61553-124-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8204 , NDC 61553-204-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8205 , NDC 61553-205-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8443 , NDC 61553-443-47 , 150 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8491 , NDC 61553-491-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9491 , NDC 61553-491-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9802 , NDC 61553-802-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 4J8205 , NDC 61553-205-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
97,716 bags, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Service Code 3V8705 , Lot Number 160380161M , Exp. Date 5/8/2016 ; Service Code 3V8705 , Lot Number 160400200M , Exp. Date 5/10/2016 ; Service Code 3V8705 , Lot Number 160460205M , Exp. Date 5/15/2016 ; Service Code 3V8705 , Lot Number…
Every code shown here, 1,999 characters
Service Code 3V8705 , Lot Number 160380161M , Exp. Date 5/8/2016 ; Service Code 3V8705 , Lot Number 160400200M , Exp. Date 5/10/2016 ; Service Code 3V8705 , Lot Number 160460205M , Exp. Date 5/15/2016 ; Service Code 3V8705 , Lot Number 160530278M , Exp. Date 5/23/2016 ; Service Code 3V8705 , Lot Number 160610204M , Exp. Date 5/31/2016 ; Service Code 3V8705 , Lot Number 160630155M , Exp. Date 6/2/2016 ; Service Code 3V8705 , Lot Number 160700159M , Exp. Date 6/9/2016 ; Service Code 3V8705 , Lot Number 160770234M , Exp. Date 6/16/2016 ; Service Code 3V8705 , Lot Number 160800199M , Exp. Date 6/19/2016 ; Service Code 3V8705 , Lot Number 160840217M , Exp. Date 6/23/2016 ; Service Code 3V8705 , Lot Number 161080171M , Exp. Date 7/17/2016 ; Service Code 3V8707 , Lot Number 160460233M , Exp. Date 5/10/2016 ; Service Code 3V8707 , Lot Number 160530170M , Exp. Date 5/17/2016 ; Service Code 3V8707 , Lot Number 160660139M , Exp. Date 5/30/2016 ; Service Code 3V8707 , Lot Number 160670160M , Exp. Date 5/31/2016 ; Service Code 3V8707 , Lot Number 160730245M , Exp. Date 6/6/2016 ; Service Code 3V8707 , Lot Number 160810188M , Exp. Date 6/14/2016 ; Service Code 3V8707 , Lot Number 160880197M , Exp. Date 6/21/2016 ; Service Code 3V8707 , Lot Number 160940223M , Exp. Date 6/27/2016 ; Service Code 3V8707 , Lot Number 160960010M , Exp. Date 6/28/2016 ; Service Code 2C8124 , Lot Number 160870072M , Exp. Date 5/11/2016 ; Service Code 2C8124 , Lot Number 160960047M , Exp. Date 5/20/2016 ; Service Code 2C8205 , Lot Number 160810170M , Exp. Date 5/6/2016 ; Service Code 2C8205 , Lot Number 160890184M , Exp. Date 5/14/2016 ; Service Code 2C8205 , Lot Number 160910167M , Exp. Date 5/15/2016 ; Service Code 2C8205 , Lot Number 160970129M , Exp. Date 5/21/2016 ; Service Code 2H8125 , Lot Number 160420030M , Exp. Date 5/8/2016 ; Service Code 2H8125 , Lot Number 160450359M , Exp. Date 5/11/2016 ; Service Code 2H8125 , Lot Number 160460339M , Exp. Date 5/12/2016 ; Service Code 2H8125 , Lot Number…
FDA’s list runs to 35,023 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Barcodes and drug codes
-
NDC
61553-125-52 -
NDC
61553-204-54 -
NDC
61553-205-50 -
NDC
61553-104-03 -
NDC
61553-124-48 -
NDC
61553-204-37 -
NDC
61553-205-02 -
NDC
61553-443-47 -
NDC
61553-491-30 -
NDC
61553-491-96 -
NDC
61553-802-96 -
NDC
61553-205-97
As FDA’s description and codes give them; the UPCs written as digits only.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 5, 2016.
- FDA classified it on Jul 16, 2016.
- FDA’s Enforcement Report published it on Jul 27, 2016.
- FDA terminated it on Mar 6, 2018.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Pharmedium Services, LLC, of Lake Forest, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 35,023 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Drug recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.