FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns
The FDA is recalling compounded progesterone pellets from Moses Lake Professional Pharmacy because the agency cannot ensure the products are sterile.
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 agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a risk of harm (lack of sterility) without reported fatalities or specific hospitalization reports falls under the 'Severe' category (Score 4), as it is not a Class I recall but involves a significant safety defect.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling compounded progesterone pellets, 50mg, 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 is a prescription-only medication consisting of 5 pellets. The recall covers lots with the following codes: t10292014@22, t09022014@13, t08262014@11, t06192015@24, and t05072014@11. The products were distributed nationwide.
Consumers and healthcare providers should stop using the recalled progesterone pellets and 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
- PROGESTERONE, Pellet, 50mg, 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)
- t10292014@22
- t09022014@13
- t08262014@11
- t06192015@24
- t05072014@11.
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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