The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0792-2017·Announced 2017-05-31

Fagron Recalls Estrone Compounding Powder Due to Quality Assurance Deviations

Fagron, Inc. is recalling Estrone for Prescription Compounding due to lack of quality assurance at the API manufacturer.

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 2/5 (Moderate).

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 involves a reasonable probability of temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is a manufacturing deviation rather than a confirmed contamination or defect causing immediate harm.

Plain-English summary

Fagron, Inc. is recalling Estrone, For Prescription Compounding, which is distributed in 1 g, 5 g, 25 g, and 100 g bottles. The product is also distributed by Freedom under the name Estrone USP, For Prescription Compounding, in the same bottle sizes. The recall involves a total of 1,313 grams of the product.

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 affected lots are distributed nationwide in the US and Puerto Rico, as well as in Australia.

Consumers and healthcare providers should stop using the recalled product and contact Fagron, Inc. or Freedom for further instructions. The specific lot numbers and expiration dates are listed in the official recall documentation.

The recalled product

Product
Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel.…
Manufacturer
Fagron, Inc
Category
Drug — Pharmaceutical 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 (17)

  • Lot #
  • Expiration Date: a) 16J05-U01-032346
  • 16G18-F003A
  • Exp. 5/17/2018
  • 16J25-U05-033898
  • Exp. 5/18/2018. b) 16F23-U04-031011
  • 16J05-U02-032345
  • 16J25-U05-033897
  • 16J25-U05-034708
  • 16J25-U05-035527
  • Exp. 5/18/2018
  • c) 16F23-U04-031024
  • 16K16-U337-033665
  • 16G18-F003
  • Exp. 5/17/2018. d) 16K16-U337-033664
  • 16J25-U05-034707
  • Exp. 5/18/2018.

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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