Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns
Qualgen, LLC is recalling Estradiol 18mg pellets because the company cannot assure the sterility of the product. The recall covers specific vial sizes 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Qualgen, LLC is voluntarily recalling Estradiol 18mg pellets, prescription-only vials available in 1, 6, 12, and 30-count packages. The recall is being conducted because the company lacks assurance of the sterility of the affected product.
The affected product includes NDC 69761-018-01, NDC 69761-018-06, NDC 69761-018-12, and NDC 69761-018-30. The specific lot involved is C255, with a beyond-use date of 12/13/2018. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected Estradiol pellets and contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) 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 (1)
- Lots: C255 BUD: 12/13/2018
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 →Related recalls
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