Recall: D-0087-2024

Class II - Potentially Harmful

Class IIClassification

2021-11-09Initiated

TerminatedStatus

PAR Sterile Products LLCFirm

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

Crystallization; identified as Buprenorphine free base

Distribution

Nationwide USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.