RXQ Compounding Recalls Inositol/Choline B12:B6 Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Inositol/Choline B12:B6 injection solution because there is 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
RXQ Compounding LLC is recalling Inositol/Choline B12:B6, 50/50/1/0.175 MG/ML INJ SOLN (Sulfa Free Lipostat), 30 ML per vial. The recall was initiated due to a lack of assurance of sterility in the product.
The affected product is identified by NDC 70731-0999-30. The recall includes all lots within expiry. The product was distributed nationwide in the United States.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Inositol/Choline B12:B6, 50/50/1/0.175 MG/ML INJ SOLN(Sulfa Free Lipostat), 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0999-30
- Manufacturer
- RXQ Compounding LLC
- 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 (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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