Prolotherapy with Phenol recalled over sterility concerns

Recall date

August 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Hartley Medical Center Pharmacy, Incorporated recalls Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5…

Recall number

D-1829-2015

FDA classification

Class I

Brand / firm

Hartley Medical Center Pharmacy, Incorporated

Sold / distributed

CA and NV

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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