FDA Recalls Compounded Chorionic Gonadotropin Syringes Due to Sterility Concerns
FDA is recalling 42 syringes of compounded chorionic gonadotropin from Moses Lake Professional Pharmacy due to lack of assurance of sterility.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the snippet, the lack of sterility in an injectable drug poses a significant risk, aligning with the Severe classification for Class II recalls with potential for serious harm.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 42 syringes of Chorionic Gonadotropin Compounded, Injectable Solution, 150 UNITS/0.150 ML per syringe. The product is manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington. The recall is classified as Class II by the FDA.
The reason for the recall is a lack of assurance of sterility. The source text indicates that all sterile human compounded drugs within expiry are affected by this issue. The distribution pattern for the recalled product is listed as nationwide.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The recall number is D-0066-2016.
The recalled product
- Product
- CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 150 UNITS/0.150 ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
- Category
- Drug — Compounded Injectable
- Affected units
- 42
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 (1)
- t07012015@9
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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