FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance
The FDA is recalling Estradiol pellets compounded by Moses Lake Professional Pharmacy because the firm cannot assure the sterility of the product.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterile compounded drugs where sterility assurance is lacking, posing a risk of infection.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Estradiol, Pellet, 9 mg, compounded by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall covers six-pellet quantities of the prescription-only medication. The product was distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The source text indicates that all sterile human compounded drugs within their expiry date are affected by this issue. Specific lot codes associated with the recall include t12052014@17, t11192014@17, t11072014@13, t07202015@15, t05142015@15, and t03052015@3.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal. The FDA classifies this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ESTRADIOL, Pellet, 9 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
- 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 (6)
- t12052014@17
- t11192014@17
- t11072014@13
- t07202015@15
- t05142015@15
- t03052015@3.
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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