The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1698-2019·Announced 2019-08-14

RXQ Compounding Recalls Procaine HCL 8% Injectable Due to Sterility Concerns

RXQ Compounding LLC is recalling Procaine HCL 8% Injectable due to a lack of 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential hospitalization or significant injury risks associated with sterility failures in injectable drugs.

Plain-English summary

RXQ Compounding LLC is recalling Procaine HCL 8% (PFV) Injectable, 10ml per vial, due to a lack of assurance of sterility. The product is identified by NDC 70731-0970-10 and is manufactured by RXQ Compounding LLC, located at 340 West State Street, Unit 9, Athens, OH 45701.

The recall includes all lots within their expiration dates. The distribution pattern for the affected product is nationwide in the United States.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. 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.

The recalled product

Product
PROCAINE HCL 8% (PFV) INJECTABLE, 10ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0970-10
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 →

Related recalls

Same manufacturer · RXQ Compounding LLC

See all →

Same hazard · lack of sterility

See all →

Similar recalls