FDAClass IOctober 7, 2015

Prolotherapy with Phenol recall: Sterility Concern

Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888

Why was Prolotherapy with Phenol recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888
Recalling firm
Hartley Medical Center Pharmacy, Incorporated
Quantity
10 vials
Distribution
CA and NV
Recall date
October 7, 2015
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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