Prolotherapy with Phenol Recall [US]

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US/Silver Spring: FDA LogoHartley Medical recalls three lots of Prolotherapy with Phenol, Injectable due to possible non-sterility, infection, organ failure and death hazards. FDA:

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Additional information:
The US Food and Drug Administration (“FDA”) reports the following Drug is subject to this recall:

Prolotherapy with Phenol is used to treat 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:

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

The recalled Drug 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 to 7/14/15.

According to the FDA, 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 (i.e., permanent organ damage) or death.

If you believe you have purchased or have in your possession the recalled Drugs, please do not consume them. Instead, kindly return the product to the outlet where you acquired it for a full refund.

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 the recalled Prolotherapy with Phenol should stop using the product and return its remaining contents to the pharmacy.

To return product or request assistance related to this recall, patients should call 1-562-595-7548, Monday through Friday, from 9:00 AM to 5:30 PM, Pacific Daylight Time. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this Drug product.


Additional information about this recall:
Recalls Direct RIN: 5720-2015
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