FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance
Moses Lake Professional Pharmacy is recalling Estradiol Pellets because the FDA determined there is a lack of assurance of sterility for the compounded drug.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a lack of sterility assurance for a sterile compounded drug which poses a risk of serious harm, align with the 'Severe' category (Score 4).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Estradiol Pellets, 3 mg, compounded by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall is classified as Class II and involves 68 pellets. The agency identified a lack of assurance of sterility for the sterile human compounded drugs within their expiry dates.
The affected product is a prescription-only medication distributed nationwide. The recall covers specific lots identified by codes such as t12092014@19 and t11252014@18, among others listed in the recall documentation. The source text does not specify the exact number of units distributed or the specific geographic locations beyond the nationwide distribution pattern.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. The recall is voluntary and initiated by the pharmacy in response to the FDA's findings regarding sterility assurance.
The recalled product
- Product
- ESTRADIOL, Pellet, 3 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
- 68
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 (16)
- t12092014@19
- t11252014@18
- t09222014@34
- t09082014@23
- t09052014@11
- t08262014@16
- t08042014@36
- t07022015@34
- t06022015@28
- t05112015@13
- t03302015@22
- t03062015@27
- t01232015@23
- t01022015@16
- 10242014@3
- 10072014@5.
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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