FDA Recalls Estradiol Pellets Due to Sterility Assurance Concerns
The FDA is recalling Estradiol pellets from JD & SN Inc. because the manufacturer cannot ensure the sterile compounded drugs are free of contamination.
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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Estradiol, Pellet, 75 mg, manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall is due to a lack of assurance of sterility for all sterile human compounded drugs within their expiration dates.
The affected product consists of 6 pellets per unit. The recall covers lots with the following codes: t11122014@22, t10282014@8, t05122015@2, t02022015@17, and t01282014@25. The distribution pattern for these products is listed as nationwide.
Consumers and healthcare providers should stop using the affected Estradiol pellets and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ESTRADIOL, Pellet, 75 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
- Category
- Drug — Compounded Sterile Drug
- Hazard
- Affected units
- 6
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 (5)
- t11122014@22
- t10282014@8
- t05122015@2
- t02022015@17
- t01282014@25.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 101 recalled by JD & SN Inc., dba Moses Lake Professional Pharmacy 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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