Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance
Qualgen, LLC is recalling Estradiol 6 mg pellets nationwide because the company cannot ensure the product is sterile.
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, which corresponds to a Severe severity score under the rubric for significant injury or property damage risks, specifically involving a lack of sterility assurance for an injectable product.
Plain-English summary
Qualgen, LLC is recalling Estradiol 6 mg pellets, available in 1, 6, 12, and 30 count vials, due to a lack of assurance of sterility. The affected products are prescription-only and were distributed nationwide. The specific lots involved are D007 with a best use date of 01/09/2019 and D060 with a best use date of 3/14/2019.
The recall was initiated because the manufacturer cannot guarantee that the pellets are sterile. This issue applies to all vials of the specified NDC numbers (69761-006-01, 69761-006-06, 69761-006-12, and 69761-006-30).
Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
- Manufacturer
- Qualgen, LLC
- Category
- Drug — Injectable 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: D007 BUD: 01/09/2019
- D060 BUD: 3/14/2019
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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