# FDA recall D-0097-2017

> **Hospira Inc., A Pfizer Company** · Class II · drug recall initiated 2016-09-16.

## Product

Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.

## Reason for recall

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0097-2017
- **Recalling firm:** Hospira Inc., A Pfizer Company
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-09-16
- **Report date:** 2016-10-19
- **Termination date:** 2019-07-31

- **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-0097-2017

## Citation

> AI Analytics. FDA recall D-0097-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0097-2017. Source: US FDA. Licensed CC0.

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