FDA Recalls Testosterone Pellets Due to Sterility Assurance Concerns
JD & SN Inc. is recalling 25 mg testosterone pellets because the agency cannot ensure the sterile compounded drugs are free from contamination.
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, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in sterile drugs) map to a score of 4 (Severe), as Class I is required for a score of 5.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Testosterone, Pellet, 25 mg, manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall is classified as Class II, indicating a situation that might cause temporary or medically reversible adverse health consequences.
The reason for the recall is a lack of assurance of sterility. The source text specifies that all sterile human compounded drugs within their expiry date are affected by this issue. The recall covers 14-pellet quantities distributed nationwide.
Consumers who have purchased these specific testosterone pellets should stop using them and contact their healthcare provider or the recalling firm for further instructions. The affected lots are identified by the codes: t12222014@29, t11122014@23, t10282014@9, t09192014@14, t08082014@3, and t03052015@6.
The recalled product
- Product
- TESTOSTERONE, Pellet, 25 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
- 14
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)
- t12222014@29
- t11122014@23
- t10282014@9
- t09192014@14
- t08082014@3
- t03052015@6.
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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