The Recall Desk
ModerateFDA (Drugs)·D-0892-2017·Announced 2017-06-14

Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

Qualgen is recalling Estradiol 18 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,361 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 due to CGMP deviations and lack of quality assurance, which fits the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/quality errors without reported injuries.

Plain-English summary

Qualgen is voluntarily recalling Estradiol 18 mg pellets, sterile for subcutaneous use, due to Current Good Manufacturing Practice (CGMP) deviations and a lack of quality assurance. The affected product is available in 1, 12, and 30 count bottles and is manufactured by Qualgen in Edmond, Oklahoma.

The recall involves 6,361 pellets distributed nationwide. Specific lots affected include C018, B151, B108, B095, B062, B035, and B133, with expiration dates ranging from May 2017 to December 2017.

Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
Manufacturer
Qualgen
Category
Drug — Hormone Therapy
Hazard
Affected units
6,361

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 (8)

  • Lot# C018
  • Exp. 08/2/17 Lot# B151
  • Exp. 12/7/17 Lot# B108
  • Exp. 10/3/17 Lot# B095
  • Exp. 09/12/17 Lot# B062
  • Exp. 07/6/17 Lot# B035
  • Exp. 05/2/17 Lot# B133
  • Exp. 11/4/17

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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