Hartley Medical Recalls Non-Sterile Prolotherapy with Phenol Vials
Hartley Medical Center Pharmacy is recalling 10 vials of Prolotherapy with Phenol due to non-sterility concerns. The product was distributed in California and Nevada.
The agency’s classification
FDA (Drugs): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which meets the criteria for a Critical severity score.
Plain-English summary
Hartley Medical Center Pharmacy, Incorporated is recalling 10 vials of Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only. The recall is being conducted due to non-sterility concerns.
The affected product is identified by Lot RX # 321608 with an expiration date of 11/01/2015. The recall is classified as Class I by the U.S. Food and Drug Administration.
The product was distributed in California and Nevada. Consumers and healthcare providers should stop using the product and contact the recalling firm at (888) 671-2888 for further instructions.
The recalled product
- Product
- Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888
- Manufacturer
- Hartley Medical Center Pharmacy, Incorporated
- Category
- Drug — Injectable
- Hazard
- Affected units
- 10
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 (2)
- Lot: RX # 321608
- Exp. 11/01/2015
Distribution
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.
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