FDA Recalls Testosterone Pellets Due to Lack of Sterility Assurance
The FDA is recalling specific lots of compounded testosterone pellets from Moses Lake Professional Pharmacy because the manufacturer cannot ensure the products are 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 rating under the rubric for significant injury risks or hospitalization reports, though no specific injuries are detailed in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Testosterone, Pellet, 106 mg, compounded by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall is due to a lack of assurance of sterility, meaning the manufacturer cannot guarantee that the sterile human compounded drugs are free from microbial contamination.
The affected product is prescription-only (Rx only) and consists of 4 pellets per unit. The recall covers specific lots with the following codes: t12082014@45, t05122015@7, t04012015@13, and t03062015@7. The distribution pattern for these products is listed as nationwide.
Consumers and healthcare providers should check their inventory or prescriptions for these specific lot codes. If you have this product, you should stop using it and contact your healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- TESTOSTERONE, Pellet, 106 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
- 4
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 (4)
- t12082014@45
- t05122015@7
- t04012015@13
- t03062015@7.
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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