The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1661-2019·Announced 2019-08-14

RXQ Compounding Recalls Folic Acid Injection Due to Sterility Concerns

RXQ Compounding LLC is recalling Folic Acid 5mg/mL Injection Solution because the product lacks 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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in an injectable product) are categorized as Severe (Score 4), as they may cause temporary or medically reversible adverse health consequences.

Plain-English summary

RXQ Compounding LLC is voluntarily recalling Folic Acid 5mg/mL Injection Solution (MDV), 10 mL per vial, NDC 70731-0924-10. 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 the expiration date. The FDA has classified this recall as Class II, indicating that 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.

Healthcare providers and patients should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions. Consumers should not use the product and should return it to the point of purchase or follow instructions from their healthcare provider.

The recalled product

Product
FOLIC ACID 5MG/ML INJECTION SOLUTION (MDV), 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0924-10
Manufacturer
RXQ Compounding LLC
Category
Drug — Injectable Solution
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.

See all 86 products in this recall →

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