The Recall Desk
SevereFDA (Drugs)·D-0226-2019·Announced 2018-11-14

Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

Qualgen, LLC is recalling Estradiol 12.5mg pellets nationwide because the company cannot ensure the product is sterile.

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 classified this recall as Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance for a drug product carries a significant risk of adverse health consequences, aligning with the Severe classification for Class II drug recalls.

Plain-English summary

Qualgen, LLC is voluntarily recalling Estradiol 12.5mg pellets in 1, 6, 12, and 30-count vials. The recall is being conducted because the company lacks assurance of the sterility of the product. The affected product is prescription-only and was distributed nationwide.

The specific lot number is C236, with a beyond-use date of 11/13/2018. The NDC codes for the affected vials are 69761-012-01, 69761-012-06, 69761-012-12, and 69761-012-30. 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.

Patients and healthcare providers should stop using the affected Estradiol pellets and contact their healthcare provider for further instructions. Qualgen, LLC is responsible for notifying customers and ensuring the product is removed from the market.

The recalled product

Product
Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Manufacturer
Qualgen, LLC
Category
Drug — Prescription Medication
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 (1)

  • Lots: C236 BUD: 11/13/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Qualgen, LLC 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 14 products in this recall →

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