RXQ Compounding Recalls Hydroxocobalamin Injections Due to Sterility Concerns
RXQ Compounding LLC is recalling Hydroxocobalamin 1000 mcg/mL injections because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
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 drug, which poses a significant risk of serious injury or hospitalization if contaminated.
Plain-English summary
RXQ Compounding LLC is recalling Hydroxocobalamin 1000 mcg/mL (PFV), 10 mL per vial, due to a lack of assurance of sterility. The product is identified by NDC 70731-0949-10. The recall includes all lots within their expiration dates.
The recall was initiated because the manufacturer could not guarantee that the product was sterile. This is a potential risk for patients receiving the injection, as non-sterile injectable products can introduce harmful microorganisms into the body.
The product was distributed nationwide in the United States. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions or alternative treatment options.
The recalled product
- Product
- HYDROXOCOBALAMIN 1000 MCG/ML (PFV), 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0949-10
- 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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