Prolotherapy with Phenol (Hartley Medical) – Non-Sterile Preparation (2015)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Hartley Medical Center Pharmacy, Incorporated
Lot Codes / Batch Numbers
Lot: RX # 323132, Exp. 10/06/2015, RX # 328690, Exp. 12/1/2015
Products Sold
Lot: RX # 323132, Exp. 10/06/2015; RX # 328690, Exp. 12/1/2015
Hartley Medical Center Pharmacy, Incorporated is recalling Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phe due to Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, NV
Page updated: Jan 7, 2026