FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance
JD & SN Inc. is recalling Estradiol pellets because the FDA determined there is a lack of assurance of sterility for all sterile human compounded drugs within their expiry.
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 rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility assurance) corresponds to a severity score of 4 (Severe), as it is not a Class I recall but involves a serious potential hazard.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Estradiol, Pellet, 12.5 mg, manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall is classified as Class II. The specific reason for the recall is a lack of assurance of sterility, which applies to all sterile human compounded drugs within their expiry date.
The affected product consists of 2 pellets per unit. The recall covers lots with codes t03132015@20 and t07072015@13. The distribution pattern for these products is listed as nationwide.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA advises patients to consult their healthcare professionals regarding alternative treatment options.
The recalled product
- Product
- ESTRADIOL, Pellet, 12.5 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
- 2
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)
- t03132015@20
- t07072015@13
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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