# FDA recall D-1368-2016

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

## Product

0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; ,	Service Code	2H8120	,	NDC	61553-120-50	,	250 ml in 250 ml Hospira LifeCare Bag 	;  ,	Service Code	2H8243	,	NDC	61553-243-54	,	200 ml in 250 ml Hospira LifeCare Bag 	;  ,	Service Code	2K8120	,	NDC	61553-120-09	,	400 ml in 500 ml Baxter Intravia Bag 	;  ,	Service Code	2K8243	,	NDC	61553-243-37	,	200 ml in 250 ml Baxter Intravia Bag 	;  ,	Service Code	2K9120	,	NDC	61553-120-03	,	500 ml in 500 ml Baxter Intravia Bag 	;  ,	Service Code	2N1120	,	NDC	61553-120-84	,	400 ml in 500 ml Baxter Intravia Bag 	;  ,	Service Code	2N9619	,	NDC	61553-619-97	,	250 ml in 250 ml Baxter Intravia Bag   	;  Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

## 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-1368-2016
- **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-1368-2016

## Citation

> AI Analytics. FDA recall D-1368-2016. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1368-2016. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*