# FDA recall D-1402-2016

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

## Product

2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), 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-1402-2016
- **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-1402-2016

## Citation

> AI Analytics. FDA recall D-1402-2016. Retrieved 2026-05-30 from https://api.ai-analytics.org/recall/D-1402-2016. Source: US FDA. Licensed CC0.

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