FDAClass IIAugust 6, 2014

Fagron recall: Sterility Concern

Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved…

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 # 14C24-U04-018189; Exp. 03/17 Lot # 14C26-U02-018214; Exp. 03/17

Product
Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved…
Recalling firm
Fagron, Inc
Quantity
97 jars
Distribution
Nationwide and Australia
Recall date
August 6, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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