The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1635-2019·Announced 2019-08-14

RXQ Compounding Recalls Ascorbic Acid Injection Due to Crystallization

RXQ Compounding LLC is recalling Ascorbic Acid 400 MG/ML Injection Solution because of 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is a voluntary, firm-initiated action for crystallization, which fits the criteria for moderate severity involving low-risk contamination or precautionary measures without reported serious injury.

Plain-English summary

RXQ Compounding LLC has voluntarily recalled Ascorbic Acid 400 MG/ML (Non-Corn) Injection Solution, 65 mL per vial, due to crystallization. The recall includes all lots within expiry and was initiated by the firm on June 19, 2019.

The product is identified by NDC 70731-0914-65 and was distributed nationwide in the United States. The FDA 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.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on return or replacement. The recall status is currently terminated.

The recalled product

Product
Ascorbic Acid 400 MG/ML (Non-Corn) Injection Solution, 65 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0914-65
Manufacturer
RXQ Compounding LLC
Category
Drug — Injection 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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