Prolotherapy with Phenol Recalled for Sterility Concerns
Hartley Medical has recently issued a voluntary recall of Prolotherapy with Phenol due to concerns of non-sterility.
About the Prolotherapy with Phenol Recall
According to the U.S. Food and Drug Administration (FDA), Hartley Medical is voluntarily recalling three lots of the injectable Prolotherapy with Phenol due to non-sterility concerns. The recall affects products distributed at the hospital/user level.
Parenteral administration of non-sterile injection products that are intended to be sterile can lead to a site-specific or systemic infection. Such an infection can result hospitalization, organ damage, or death. So far, Hartley Medical has not received any reports of product contamination or adverse events.
The FDA recommends that consumers, distributors, and retailers who have Prolotherapy with Phenol discontinue use of the product and return its remaining contents to the pharmacy.
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.
Description of the Prolotherapy with Phenol Recall
- 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.
- 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)