RXQ Compounding Recalls EDETATE CALCIUM DISODIUM INJECTABLE Due to Sterility Concerns
RXQ Compounding LLC is recalling EDETATE CALCIUM DISODIUM 150MG/ML INJECTABLE vials because the product lacks 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 no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug represents a significant risk of harm, aligning with the Severe classification for high-risk products where injury has not yet been reported but the hazard is significant.
Plain-English summary
RXQ Compounding LLC is recalling EDETATE CALCIUM DISODIUM 150MG/ML INJECTABLE, 100 ML per vial (NDC: 70731-0934-11). The recall is being conducted because the product lacks assurance of sterility.
The affected product was distributed nationwide in the United States. The recall includes all lots within their expiration dates.
Healthcare providers and patients should stop using the recalled product and contact their healthcare provider for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- EDETATE CALCIUM DISODIUM 150MG/ML INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0934-11
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Injectable
- Hazard
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)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by RXQ Compounding LLC 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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