Fagron Recalls Pentravan Plus Base Due to Mold Contamination
Fagron is recalling specific lots of Pentravan Plus Base, a prescription compounding ingredient, because of mold contamination.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves microbial contamination (mold) in a product used for prescription compounding. Per the rubric, high-risk pathogens or contamination without reported illness corresponds to a High severity score.
Plain-English summary
Fagron, Inc. is recalling six lots of Pentravan Plus Base, a 2.5 kg oil-in-water emulsion base used for prescription compounding. The recall is being conducted due to the presence of mold in the product.
The affected product is identified by Article number 804749 and NDC 51552-1285-8. The specific lots subject to the recall are Lot # 14C03-U09-017846 and Lot # 14B28-U06-017824, both with an expiration date of 03/17. The recall covers 99 jars of the product.
The product was distributed nationwide and in Australia. It is intended for prescription compounding only. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots.
The recalled product
- Product
- Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent for use with high concentrations of active ingredients.Pre served and…
- Manufacturer
- Fagron, Inc
- Category
- Drug — Compounding Ingredient
- Affected units
- 99
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 (3)
- Lot # 14C03-U09-017846
- Exp. 03/17 Lot # 14B28-U06-017824
- Exp. 03/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Fagron, Inc 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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