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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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.
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