April 2017 FDA Recall Buprenorphine Hydrochloride by Par Sterile Products Llc
D-0698-2017 - Crystallization

This Class II drug recall was voluntarily initiated by Par Sterile Products Llc on April 28, 2017 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-0698-2017

Reason for Recall
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Initiated
04-28-2017
Reported
05-17-2017
Quantity
122,469 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77169
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 in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2018
Product Description About Product Description
Full technical description of the product.
Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977.

Batch or Lot Expiration Information

Lot# : 821102, 821103, Exp 01/18; 821104, 821106, 821107, Exp 02/18; 821108, Exp 03/18; 821884, 821885, Exp 07/18; 821886, 821887, Exp 08/18; 822767, Exp 09/18; 824183, Exp 10/18.

Affected Packages Involved in this Recall

42023-179-05 Buprenorphine Hydrochloride
42023-179-01 Buprenorphine Hydrochloride