FDA recall D-0087-2024

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

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

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