# FDA recall D-0087-2024

> **PAR Sterile Products LLC** · Class II · drug recall initiated 2021-11-09.

## Product

Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05

## Reason for recall

Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0087-2024
- **Recalling firm:** PAR Sterile Products LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-11-09
- **Report date:** 2023-11-15
- **Termination date:** 2024-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0087-2024

## Citation

> AI Analytics. FDA recall D-0087-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0087-2024. Source: US FDA. Licensed CC0.

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