FDA Recalls Compounded Chorionic Gonadotropin Injectable Solution Due to Sterility Concerns
FDA is recalling 64 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable drug with a lack of assurance of sterility falls under the 'Severe' category (Score 4), as it represents a significant risk of harm.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for 64 syringes of CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 500 UNITS/0.5ML per syringe. The product is prescription-only and was manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington.
The recall was initiated due to a lack of assurance of sterility for all sterile human compounded drugs within their expiry date. The affected product codes are t03272015@13 and t04292015@14. The distribution pattern 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 FDA classifies this as a Class II recall.
The recalled product
- Product
- CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 500 UNITS/0.5ML 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
- 64
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)
- t03272015@13 and t04292015@14
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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