Prolotherapy with Phenol by Hartley Medical: Recall - Non-sterility Concerns

AUDIENCE: Nursing, Pharmacy, Pain Management, Risk Manager, Compounding

ISSUE: Hartley Medical is recalling three lots of Prolotherapy with Phenol, Injectable to the hospital/user level due to non-sterility concerns. This recall is a voluntary measure taken following a recent inspection with issues on Hartley's sterility methods and testing procedures specifically for this preparation. 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.

The affected Prolotherapy with Phenol lots include the following lot numbers and expiration dates:

RX328690 Expires 12/1/2015
RX323132 Expires 10/6/2015
RX321608 Expires 11/1/2015

BACKGROUND: 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 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.

RECOMMENDATION: Consumers/distributors/retailers that have affected Prolotherapy with Phenol product should stop using the product and return 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm458832.htm