The Recall Desk
ModerateFDA (Drugs)·D-0889-2017·Announced 2017-06-14

Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

Qualgen is recalling Estradiol 25 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,153 pellets distributed nationwide.

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, but the source text cites CGMP deviations and lack of quality assurance without reporting specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Qualgen is recalling Estradiol 25 mg pellets (NDC 69761-025-01) in 1, 12, and 30 count bottles. The product is sterile, for subcutaneous use only, and requires a prescription. The recall involves 1,153 pellets distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and a lack of quality assurance. Specific lot numbers and expiration dates are listed in the recall documentation.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or Qualgen for further instructions.

The recalled product

Product
Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,
Manufacturer
Qualgen
Category
Drug — Prescription Pellets
Hazard
Affected units
1,153

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 (4)

  • Lot # C031
  • Exp. 03/2/18 Lot # B077
  • Exp. 08/10/17 Lot # B040
  • Exp. 05/16/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Qualgen 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 8 products in this recall →

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