The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1717-2019·Announced 2019-08-14

RXQ Compounding Recalls Vitamin B Complex 100 Due to Sterility Concerns

RXQ Compounding LLC is recalling Vitamin B Complex 100 vials because the product may lack 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, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While the source does not explicitly mention hospitalizations, the 'Lack of Assurance of Sterility' for an injectable/compounded product represents a significant risk of serious adverse health consequences, aligning with the Severe criteria for significant injury reports or high-risk defects.

Plain-English summary

RXQ Compounding LLC is recalling Vitamin B Complex 100 (PFV) vials, available in 2 mL and 30 mL sizes, due to a lack of assurance of sterility. The recalled products are identified by NDC 70731-0961-02 (2 mL) and NDC 70731-0961-30 (30 mL). The recall covers all lots within their expiration dates.

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. The distribution of these products was nationwide in the United States.

Consumers and healthcare providers should stop using the recalled Vitamin B Complex 100 vials and contact their healthcare provider or the recalling firm for further instructions. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
VITAMIN B COMPLEX 100 (PFV), [2 or 30 ML] per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 2 ML Vial: 70731-0961-02; NDC 30 ML Vial: 70731-0961-30
Manufacturer
RXQ Compounding LLC
Category
Drug — Compounded Medication
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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