The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1667-2019·Announced 2019-08-14

RXQ Compounding Recalls Hydroxocobalamin Injections Due to Sterility Concerns

RXQ Compounding LLC is recalling Hydroxocobalamin 1000 mcg/mL injections 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in injectable drugs) fall under the Severe category, and the rule states that FDA Class I or II classifications generally warrant a score of 4 or higher if significant risk is present, though strictly Class II is often 3 or 4. Given the 'Lack of Assurance of Sterility' for an injectable, which poses a direct risk of serious infection (sepsis, etc.), it aligns with the 'Severe' criteria for significant injury potential.

Plain-English summary

RXQ Compounding LLC is recalling Hydroxocobalamin 1000 mcg/mL (MDV), 30 mL per vial, NDC 70731-0926-30. The recall is due to a lack of assurance of sterility in the product. The affected product was distributed nationwide in the United States.

The source text does not specify the number of units recalled, specific lot numbers, or the exact dates of distribution. It indicates that all lots within the expiry date are affected. No illnesses or injuries have been reported in the source text.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions. The FDA classifies 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.

The recalled product

Product
HYDROXOCOBALAMIN 1000 MCG/ML (MDV), 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0926-30
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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