The Recall Desk
SevereFDA (Drugs)·D-1497-2014·Announced 2014-08-06

Fagron Recalls Pentravan Base Due to Mold Contamination

Fagron is recalling six lots of Pentravan Base 2.5 Kg due to the presence of mold. The product is used for prescription compounding.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for serious adverse health consequences (such as microbial contamination) are categorized as Severe.

Plain-English summary

Fagron, Inc. is recalling six lots of Pentravan Base 2.5 Kg, Article number 802486, due to the presence of mold. The product is an oil-in-water emulsion used for prescription compounding and is available by prescription only. The recall involves 97 jars distributed nationwide and in Australia.

The affected lots are identified by the following codes: Lot # 14C24-U04-018189 (Expiration 03/17) and Lot # 14C26-U02-018214 (Expiration 03/17). The product is manufactured by Fagron, Inc. in St. Paul, Minnesota.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or Fagron for further instructions. The recall is classified as FDA Class II.

The recalled product

Product
Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 NDC 51552-0919-8.
Manufacturer
Fagron, Inc
Category
Drug — Compounding Ingredient
Hazard
Affected units
97

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

See all 3 products in this recall →

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