The Recall Desk
ModerateFDA (Drugs)·D-0891-2017·Announced 2017-06-14

Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

Qualgen is recalling Estradiol 20 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,468 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 20 mg pellets, manufactured in 1-count and 12-count bottles for subcutaneous use. The recall involves 4,468 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 products and contact Qualgen or their healthcare provider for instructions on return or replacement.

The recalled product

Product
Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01
Manufacturer
Qualgen
Category
Drug — Hormone Pellets
Hazard
Affected units
4,468

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 (6)

  • Lot# C022
  • Exp. 08/21/17 Lot# B143
  • Exp. 11/22/17 Lot# B104
  • Exp. 09/27/17 Lot# B073
  • Exp. 08/1/17 Lot# B052
  • Exp. 06/13/17

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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