RXQ Compounding Recalls Pyridoxine Vials Due to Sterility Concerns
RXQ Compounding LLC is recalling Pyridoxine (MDV) 100mg/mL vials 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 FDA classified this as a Class II recall. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable/compounded drugs) align with a Severe rating, especially given the lack of sterility assurance which poses a risk of infection.
Plain-English summary
RXQ Compounding LLC is recalling Pyridoxine (MDV) 100mg/mL, 30mL per vial (NDC: 70731-0956-30) due to a lack of assurance of sterility. The product is a prescription compounding manufactured by RXQ Compounding LLC, located in Athens, Ohio.
The recall includes all lots within expiry. The distribution pattern is listed as nationwide in the United States. The FDA has classified this recall as Class II, indicating a situation where 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 and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions or a replacement. No specific lot numbers or dates are provided in the source text beyond the general instruction to check all lots within expiry.
The recalled product
- Product
- PYRIDOXINE (MDV) 100MG/ML, 30ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0956-30
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Compounded Prescription
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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