The Recall Desk
SevereFDA (Drugs)·D-0890-2017·Announced 2017-06-14

Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

Qualgen is recalling Estradiol 22 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,666 pellets distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this recall as Class II. According to the rubric, an FDA Class II recall with potential for adverse health consequences corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Critical (Class I) but is more significant than High (theoretical risk/no reported illness).

Plain-English summary

Qualgen is voluntarily recalling Estradiol 22 mg pellets (NDC 69761-022-01) in 1, 12, and 30 count bottles. The product is sterile, for office use only, and intended for subcutaneous use. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations and a lack of quality assurance.

The affected lots are Lot # B128 (Expiration 11/1/17) and Lot # B075 (Expiration 08/3/17). A total of 1,666 pellets were distributed nationwide. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Patients who have received these pellets should contact their healthcare provider for guidance. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
Estradiol 22 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 69761-022-01
Manufacturer
Qualgen
Category
Drug — Hormone Pellets
Hazard
Affected units
1,666

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 (3)

  • Lot # B128
  • Exp. 11/1/17 Lot # B075
  • Exp. 08/3/17

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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