FDA Recalls Testosterone Pellets Due to Lack of Sterility Assurance
FDA is recalling specific lots of compounded testosterone pellets because they lack assurance of sterility. Patients should contact their healthcare provider.
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. According to the rubric, an FDA Class II recall with potential for adverse health consequences (lack of sterility) corresponds to a score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but is more severe than a theoretical risk without reported illness.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific lots of compounded testosterone pellets manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall is due to a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates.
The affected product is Testosterone, Pellet, 60 mg, Rx only. The specific lot codes involved are t12082014@41, t09152014@40, t08062014@5, and t02112015@16. Each package contains 4 pellets. The distribution pattern is listed as nationwide.
Patients who have received these specific lots of testosterone pellets should contact their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- TESTOSTERONE, Pellet, 60 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@41
- t09152014@40
- t08062014@5
- t02112015@16.
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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