The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1659-2019·Announced 2019-08-14

RXQ Compounding Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns

RXQ Compounding LLC is recalling Fentanyl and Bupivacaine syringes nationwide due to 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a drug product, which poses a risk of harm without reported illnesses.

Plain-English summary

RXQ Compounding LLC is voluntarily recalling Fentanyl 2mcg/mL Bupivacaine 0.125% in NaCl 0.9% Syringe C-II, 50mL per syringe. The recall is being conducted due to a lack of assurance of sterility for the product.

The affected product is identified by NDC 70731-0207-89. The recall covers all lots within the expiration date. The product was distributed nationwide in the United States.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions or a replacement.

The recalled product

Product
FENTANYL 2MCG/ML BUPIVACAINE 0.125% IN NACL 0.9% SRY C-II, 50ML per syringe (C-II) RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0207-89
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 →

Related recalls

Same manufacturer · RXQ Compounding LLC

See all →

Same hazard · sterility

See all →

Similar recalls