Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance
Qualgen, LLC is recalling Estradiol 15mg pellets because the company cannot ensure the products are sterile. The recall covers specific lots 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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility assurance (which implies potential for serious injury or hospitalization) corresponds to a severity score of 4 (Severe).
Plain-English summary
Qualgen, LLC is recalling Estradiol 15mg pellets in 1, 6, 12, and 30 count vials. The recall is being conducted because the company lacks assurance of the sterility of the affected products. The specific lots involved are C253 with a beyond-use date of 12/12/2018, and D016 with a beyond-use date of 1/18/2019.
The affected products were distributed nationwide. These are prescription-only items manufactured by Qualgen, LLC in Edmond, Oklahoma. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or the manufacturer for further instructions. No specific illness or injury reports are mentioned in the source text, but the lack of sterility assurance presents a potential risk of infection.
The recalled product
- Product
- Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
- Manufacturer
- Qualgen, LLC
- Category
- Drug — Prescription 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 (2)
- Lots: C253 BUD: 12/12/2018
- D016 BUD: 1/18/2019
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.
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