The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0229-2019·Announced 2018-11-14

Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

Qualgen, LLC is recalling Estradiol 25mg pellets because the company cannot assure the sterility of the product. The recall covers specific lots distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the severity rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance) are categorized as Severe (Score 4), particularly when structural or sterility defects are involved which carry significant risk.

Plain-English summary

Qualgen, LLC is recalling Estradiol 25mg 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 C238, with a beyond-use date of 11/14/2018. The National Drug Codes (NDCs) for the affected vials are 69761-025-01, 69761-025-06, 69761-025-12, and 69761-025-30. The product was manufactured by Qualgen, LLC in Edmond, Oklahoma.

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

The recalled product

Product
Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Manufacturer
Qualgen, LLC
Category
Drug — Sterile Pellets
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: C238 BUD: 11/14/2018

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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