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.
What this means for you
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.
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