FDAClass IIAugust 6, 2014

Fagron recall: Sterility Concern

Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for…

Why was Fagron recalled?

Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

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 # 13J30-U17-015413; Exp 10/15 Lot # 13J30-U16-015425; Exp 10/15 Lot # 13I06-U05-014199; Exp 10/15

Product
Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for…
Recalling firm
Fagron, Inc
Quantity
430 jars
Distribution
Nationwide and Australia
Recall date
August 6, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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