The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1681-2019·Announced 2019-08-14

RXQ Compounding Recalls MIC B12 W/B6 Due to Sterility Concerns

RXQ Compounding LLC is recalling MIC B12 W/B6 (Lipostat Plus) vials because the FDA identified a lack of 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 hazard involves a lack of assurance of sterility, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

RXQ Compounding LLC is recalling MIC B12 W/B6 (Lipostat Plus) 25/50/50/1/.175 mg/ml, 30 ml vials. The recall was initiated due to a lack of assurance of sterility in the product. The affected product is identified by NDC 70731-0978-30 and includes all lots within their expiration dates.

The recall is classified as FDA Class II by the U.S. Food and Drug Administration. The distribution pattern for the recalled product is nationwide in the United States.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions. The recall is managed by RXQ Compounding LLC, located at 340 West State Street, Unit 9, Athens, OH 45701.

The recalled product

Product
MIC B12 W/B6 (LIPOSTAT PLUS) 25/50/50/1/.175 MG/ML, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0978-30
Manufacturer
RXQ Compounding LLC
Category
Drug — Compounded 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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