FDA Recalls Chorionic Gonadotropin/Cyanocobalamin Syringes Due to Sterility Concerns
JD & SN Inc. is recalling 26 syringes of Chorionic Gonadotropin/Cyanocobalamin Injectable Solution nationwide due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug presents a significant risk profile consistent with the Severe category for Class II drug recalls.
Plain-English summary
JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling 26 syringes of Chorionic Gonadotropin/Cyanocobalamin Injectable Solution. The product is a prescription-only injectable solution containing 2000 units of chorionic gonadotropin and 1mg/mL of cyanocobalamin per syringe. The recall is being conducted because there is a lack of assurance of sterility for all sterile human compounded drugs within their expiry date.
The affected product was distributed nationwide. The specific code information for the recalled items is t05192015@19. The FDA has 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, or where the probability of serious adverse health consequences is remote.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm, JD & SN Inc., for further instructions on disposal or replacement. The firm can be reached at (509) 764-2314 or at 1555 S. Pilgrim St., Moses Lake, WA 98837.
The recalled product
- Product
- CHORIONIC GONADOTROPIN/CYANOCOBALAMIN, Injectable Solution, 2000 unit/1mg/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 — Injectable Solution
- Affected units
- 26
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)
- t05192015@19
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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