Moses Lake Pharmacy Recalls Chorionic Gonadotropin Due to Sterility Concerns
JD & SN Inc. is recalling specific vials of Chorionic Gonadotropin injectable solution because the agency could not ensure the sterile human compounded drugs were 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 FDA classified this as a Class II recall. Per the rubric, an FDA Class II recall involving a sterile injectable drug where sterility assurance is lacking is classified as Severe (Score 4) due to the potential for significant injury or adverse health consequences.
Plain-English summary
JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling specific vials of Chorionic Gonadotropin, Injectable Solution, 5000 UNITS/0.1 mL. The recall involves vials in 5 mL, 6 mL, 8 mL, and 10 mL sizes. The total quantity recalled is 9 (5mL) vials, 2 (6mL) vials, 8 (8mL) vials, and 2 (10mL) vials.
The recall was initiated due to a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates. The FDA classified 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 affected products were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot codes listed in the recall notice and stop using the affected vials. Those who have questions regarding the recall should contact the recalling firm at (509) 764-2314.
The recalled product
- Product
- CHORIONIC GONADOTROPIN, Injectable Solution, 5000 UNITS/0.1 mL, vial sizes: 5 mL; 6 mL; 8 mL; 10 mL, 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
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 (18)
- t12292014@35
- t12192014@15
- t12162014@29
- t10232014@24
- t09162014@29
- t09032014@6
- t07252014@16
- t07142015@6
- t07022015@8
- t06152015@32
- t05272015@33
- t04282015@11
- t04162015@34
- t04092015@8
- t04022015@30
- t02262015@24
- t02032015@21
- and t01232015@10
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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