The Recall Desk
ModerateFDA (Drugs)·D-0791-2017·Announced 2017-05-31

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 and involves cGMP deviations regarding quality assurance without reported illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

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 US, Puerto Rico, and Australia. The recall also includes Estriol USP Micronized, For prescription compounding, in 100 g bottles distributed by Freedom.

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. The source text does not report any illnesses or injuries associated with the product.

Consumers and healthcare providers should stop using the affected products and contact Fagron, Inc. at 1-(800) 423-6967 for further instructions.

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), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(8
Manufacturer
Fagron, Inc
Category
Drug — Prescription Compounding
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 (20)

  • Lot #
  • Expiration Date: a) 1 G bottle: 16D08-U02-030005
  • Exp. 3/6/2018
  • 16F23-U05-033657
  • Exp. 5/26/2018
  • 17C02-U02-035889
  • Exp. 1/19/2019. b) 5 G bottle: 16D08-U02-030004
  • 16D08-U02-032486
  • 16F23-U05-033656
  • 16F23-U05-035093
  • 17C02-U02-035890
  • Exp. 1/19/2019. c) 25 G bottle: 16D08-U02-030003
  • 16D08-U02-032475
  • 16F23-U05-033655
  • 16F23-U05-035092
  • 17C02-U02-035887
  • Exp. 1/19/2019. d) 100 G bottle: 16D08-U02-030002
  • 16D08-U02-032474
  • 16F23-U05-031158
  • 16F23-U05-033654

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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