November 2021 FDA Recall Buprenorphine Hydrochloride by Par Sterile Products Llc
D-0087-2024 - Crystallization

This Class II drug recall was voluntarily initiated by Par Sterile Products Llc on November 9, 2021 for the product Buprenorphine Hydrochloride. The FDA reported the reason for recall as crystallization. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0087-2024

Reason for Recall
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Initiated
11-09-2021
Reported
11-15-2023
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89016
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PAR Sterile Products LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2024
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot No: 343716, Exp. Date: 11/2021; Lot No: 350565, Exp. Date: 07/2022; Lot No: 26921, Exp. Date: 07/2022; Lot No: 36227, Exp. Date: 02/2023

Affected Packages Involved in this Recall

42023-179-05 Buprenorphine Hydrochloride