FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns
JD & SN Inc. is recalling compounded progesterone pellets because the agency cannot ensure they are sterile. Consumers should stop using the product and 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 source text identifies the recall as FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterile compounded drugs where sterility assurance is lacking, posing a risk of infection.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for compounded progesterone pellets, 200 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 expiration dates.
The affected product consists of 5 pellets per package. The recall covers lots with the following codes: t08042014@18, t07082015@26, t07072015@12, t03132015@6, and t02162015@12. The product was distributed nationwide.
Consumers who have this product should stop using it and contact their healthcare provider for further instructions. The FDA classifies this as a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PROGESTERONE, Pellet, 200 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
- 5
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 (5)
- t08042014@18
- t07082015@26
- t07072015@12
- t03132015@6
- t02162015@12.
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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