The Recall Desk
SevereFDA (Drugs)·D-1699-2019·Announced 2019-08-14

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.

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 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

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.

See all 86 products in this recall →