# FDA recall D-0564-2024

> **Pfizer Inc.** · Class II · drug recall initiated 2024-05-20.

## Product

Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC:  0409-2012-03

## Reason for recall

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

## Distribution

US Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-0564-2024
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-05-20
- **Report date:** 2024-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0564-2024

## Citation

> AI Analytics. FDA recall D-0564-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0564-2024. Source: US FDA. Licensed CC0.

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