The Recall Desk
SevereFDA (Drugs)·D-1829-2015·Announced 2015-10-07

Hartley Medical Recalls Prolotherapy with Phenol Vials Due to Non-Sterility

Hartley Medical Center Pharmacy is recalling 14 vials of Prolotherapy with Phenol due to non-sterility concerns. The product was distributed in California and Nevada.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or higher.

Plain-English summary

Hartley Medical Center Pharmacy, Incorporated is recalling 14 vials of Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI). The recall is being conducted due to non-sterility concerns regarding the product.

The affected product is a 5 mL vial, prescription-only medication. The specific lots involved are RX # 323132 (Expiration 10/06/2015) and RX # 328690 (Expiration 12/1/2015). The product was distributed in California and Nevada.

Consumers and healthcare providers who have this product should stop using it and contact Hartley Medical at (888) 671-2888 for further instructions.

The recalled product

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
Manufacturer
Hartley Medical Center Pharmacy, Incorporated
Category
Drug — Injectable
Hazard
Affected units
14

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot: RX # 323132
  • Exp. 10/06/2015
  • RX # 328690
  • Exp. 12/1/2015

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Hartley Medical Center Pharmacy, Incorporated under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Hartley Medical Center Pharmacy, Incorporated

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Same hazard · non sterility

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