The Recall Desk
ModerateFDA (Drugs)·D-0079-2018·Announced 2017-11-22

Fagron Recalls Estriol Compounding Powder Due to Quality Assurance Deviations

Fagron, Inc. is recalling Estriol for prescription compounding due to lack of quality assurance at the API manufacturer.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. The source cites cGMP deviations without reporting specific injuries or illnesses, aligning with a moderate severity rating for a voluntary precautionary recall based on manufacturing quality issues.

Plain-English summary

Fagron, Inc. is recalling Estriol, For Prescription Compounding, in 1 g, 5 g, 25 g, and 100 g bottles. The product is distributed nationwide in the USA. The recall involves a total of 934 grams of the product across specific lot numbers and expiration dates.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations, specifically a lack of quality assurance at the active pharmaceutical ingredient (API) manufacturer. This classification is designated as Class II by the FDA.

Healthcare providers and pharmacies should stop using the affected lots and contact Fagron, Inc. for further instructions. Consumers should not use the product and should return it to the point of purchase or contact the distributor.

The recalled product

Product
Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1
Manufacturer
Fagron, Inc
Category
Drug — Compounding Ingredient
Hazard

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 (9)

  • Lot #
  • Expiration Date: a) 1 G bottle: 16F23-U05-033657
  • Exp. 5/26/2017. b) 5 G bottle: 16F23-U05-033656
  • Exp. 5/26/2018
  • 17C02-U02-035890
  • Exp. 1/19/2019. c) 25 G bottle: 16F23-U05-033655
  • 17C02-U02-035887
  • Exp. 1/19/2019. d) 100 G bottle: 17C02-U02-035888
  • Exp. 1/19/2019

Distribution

Distributed nationwide across the United States.

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