FDA Recalls Chorionic Gonadotropin Vials Due to Sterility Concerns
The FDA is recalling 9 vials of Chorionic Gonadotropin Injectable Solution from Moses Lake Professional Pharmacy due to a 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection from non-sterile injectable drugs.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Chorionic Gonadotropin, Injectable Solution, 4000 UNITS/mL, 8 mL vials. The product is recalled because there is a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates.
The recall involves 9 vials manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington. The agency has classified this as a Class II recall. The distribution pattern is listed as nationwide.
Consumers and healthcare providers should stop using the affected vials and contact the recalling firm or their healthcare provider for further instructions. The specific lot codes associated with this recall are t05062015@33, t08212014@16, and t02032015@14.
The recalled product
- Product
- CHORIONIC GONADOTROPIN, Injectable Solution, 4000 UNITS/ mL, 8 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
- Category
- Drug — Injectable Solution
- Affected units
- 9
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 (3)
- t05062015@33
- t08212014@16
- t02032015@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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