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Safety

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Hartley Medical Issues Voluntary Recall of Prolotherapy with Phenol Due to Non-sterility Concerns

Contact:
Consumer:
William Stuart: (562) 595-7548

FOR IMMEDIATE RELEASE — August 17, 2015 — Long Beach, California — Hartley Medical is voluntarily recalling three lots of Prolotherapy with Phenol, Injectable to the hospital/user level due to non-sterility concerns.

Parenteral administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or a fatal outcome. To date Hartley Medical has not received any reports of product contamination and/or adverse events related to this recall. This recall is a voluntary measure taken following a recent inspection with issues on our sterility methods and testing procedures specifically for this preparation.

Prolotherapy with Phenol is used for neurolysis and is packaged in clear 5 mL and/or 100 mL sterile vials with labeling of the pharmacy and the drug. The affected Prolotherapy with Phenol lots include the following lot numbers and expiration dates:

RX328690Expires 12/1/2015
RX323132Expires 10/6/2015
RX321608Expires 11/1/2015
 

The product can be identified by its white label on each vial with the name “PROLOTHERAPY WITH PHENOL”. Product was distributed in California and Nevada to pain clinics between 5/15/15 – 7/14/15.

Hartley Medical is notifying its distributors and customers by telephone, facsimile, electronic mail and/or regular mail and is arranging a return of all recalled products. Consumers/distributors/retailers that have Prolotherapy with Phenol which is being recalled should stop using the product and return its remaining contents to the pharmacy.

To return product or request assistance related to this recall, users should call (562) 595-7548, Monday through Friday, from 9:00 a.m. to 5:30 p.m. PDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Page Last Updated: 08/20/2015
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