FDA Recalls NDC 42023-179 Buprenorphine Hydrochloride
Injection Intramuscular; Intravenous

FDA Recalls Enforcement Reports

The last Recall Enforcement Report for Buprenorphine Hydrochloride with NDC 42023-179 was initiated on 04-28-2017 as a Class II recall due to 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. The latest recall number for this product is D-0698-2017 and the recall is currently terminated as of 03-29-2018 .

Recall Number D-0698-2017

Field Name Field Value
Event ID 77169 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0698-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide in the USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description 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.
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. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 122,469 cartons Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 05-17-2017
Recall Initiation Date 04-28-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 03-29-2018 What is the Date Terminated?
The date that FDA terminated the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm PAR Sterile Products LLC
Code Info 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. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 42023-179-05; 42023-179-01
Status Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.