The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1634-2019·Announced 2019-08-14

RXQ Compounding Recalls Ascorbic Acid Injection Due to Crystallization

RXQ Compounding LLC is voluntarily recalling Ascorbic Acid 500 MG/ML Injection due to crystallization. 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 recall as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when specific defects like crystallization in injectable drugs are involved.

Plain-English summary

RXQ Compounding LLC has initiated a voluntary recall of Ascorbic Acid 500 MG/ML (Non-Corn) Injection (PFV), 50 mL per vial. The recall was initiated on June 19, 2019, and the product is identified by NDC 70731-0173-10.

The reason for the recall is crystallization within the product. The FDA classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences. The recall covers all lots within their expiration dates.

The product was distributed nationwide in the United States. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions or a replacement.

The recalled product

Product
Ascorbic Acid 500 MG/ML (Non-Corn) Injection (PFV), 50 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0173-10
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.

See all 86 products in this recall →

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