PlainRecalls
FDA Drug Critical Class I Terminated

Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial, Rx Only, Hartley Medical, (888) 671-2888

Reported: October 7, 2015 Initiated: August 17, 2015 #D-1829-2015

Product Description

Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial, Rx Only, Hartley Medical, (888) 671-2888

Reason for Recall

Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.

Details

Units Affected
14 vials
Distribution
CA and NV
Location
Long Beach, CA

Frequently Asked Questions

What product was recalled?
Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial, Rx Only, Hartley Medical, (888) 671-2888. Recalled by Hartley Medical Center Pharmacy, Incorporated. Units affected: 14 vials.
Why was this product recalled?
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 7, 2015. Severity: Critical. Recall number: D-1829-2015.