The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1677-2019·Announced 2019-08-14

RXQ Compounding Recalls Methylcobalamin Injectable Solution Due to Sterility Concerns

RXQ Compounding LLC is recalling Methylcobalamin 10mg/ml Injectable Solution because the product lacks assurance of sterility. 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in an injectable) map to a severity score of 4 (Severe), as they represent a significant risk even if not explicitly Class I.

Plain-English summary

RXQ Compounding LLC is voluntarily recalling Methylcobalamin 10mg/ml Injectable Solution (MDV), 10 ML per vial, NDC 70731-0130-10. The recall was initiated because the product lacks assurance of sterility. This is an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recall covers all lots of the product within their expiration dates. The product was distributed nationwide in the United States. Methylcobalamin is a form of vitamin B12 used in injectable form.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. Patients should not attempt to dispose of the medication themselves without guidance.

The recalled product

Product
METHYLCOBALAMIN 10MG/ML INJECTABLE SOLUTION (MDV), 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0130-10
Manufacturer
RXQ Compounding LLC
Category
Drug — Injectable 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 →

Related recalls

Same manufacturer · RXQ Compounding LLC

See all →

Same hazard · lack of sterility

See all →

Similar recalls