FDA Recalls Testosterone Pellets Due to Sterility Assurance Concerns
FDA is recalling specific lots of compounded testosterone pellets because the manufacturer cannot ensure sterility. Patients should contact their healthcare provider.
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 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 compromised.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific lots of TESTOSTERONE, Pellet, 115 mg, 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 a prescription-only medication consisting of 7 pellets per unit. The recall covers lots with the following codes: t06022015@27, t05272015@37, t05222015@16, t03232015@16, t03062015@36, t01132015@8, and t01082015@15. The distribution pattern is listed as nationwide.
Patients who have received this medication should contact their healthcare provider or pharmacist for instructions on what to do next. The FDA has classified 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, 115 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
- 7
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 (7)
- t06022015@27
- t05272015@37
- t05222015@16
- t03232015@16
- t03062015@36
- t01132015@8
- t01082015@15.
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.
See all 101 products in this recall →Related recalls
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