# FDA recall D-1396-2016

> **Pharmedium Services, LLC** · Class II · drug recall initiated 2016-05-05.

## Product

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 Ba

## Reason for recall

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1396-2016
- **Recalling firm:** Pharmedium Services, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-05-05
- **Report date:** 2016-07-27
- **Termination date:** 2018-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1396-2016

## Citation

> AI Analytics. FDA recall D-1396-2016. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1396-2016. Source: US FDA. Licensed CC0.

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