# FDA recall D-1367-2016

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

## Product

0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag,  Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), 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-1367-2016
- **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-1367-2016

## Citation

> AI Analytics. FDA recall D-1367-2016. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1367-2016. Source: US FDA. Licensed CC0.

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