Multi-event August 2015 FDA Recall Drug by Hartley Medical Center Pharmacy, Incorporated

This Multi-event Class I drug recall was voluntarily initiated by Hartley Medical Center Pharmacy, Incorporated on August 17, 2015 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed in CA and NV and the recall is currently terminated.

Reported Recall Events

D-1830-2015 TERMINATED D-1829-2015 TERMINATED

Recall Number: D-1830-2015

Reason for Recall
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Initiated
08-17-2015
Reported
10-07-2015
Quantity
10 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71990
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is 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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA and NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-30-2015
Product Description About Product Description
Full technical description of the product.
Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888

Batch or Lot Expiration Information

Lot# Lot: RX # 321608, Exp. 11/01/2015

Recall Number: D-1829-2015

Reason for Recall
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Initiated
08-17-2015
Reported
10-07-2015
Quantity
14 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71990
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is 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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hartley Medical Center Pharmacy, Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA and NV
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-30-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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