Agency classClass IIOur severity:High FDA (Drugs)·D-1278-2022·Announced 2022-07-27

Compounded Sterile Injectable Recalled Due to Lack of Sterility Assurance

Nephron Sterile Compounding Center LLC is recalling 2210 syringes of a three-drug compounded injectable due to 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 product is a sterile injectable where contamination poses significant risk to patient safety; however, no illnesses or injuries have been reported. Under the rubric, this is a 'risk-of-harm product where injury has not yet been reported,' warranting a High severity score.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling 2210 pre-filled syringes of a compounded sterile injectable containing ropivacaine HCl, clonidine HCl, and ketorolac tromethamine. Affected lot numbers are RP2003A and RP2003B, both expiring July 20, 2022. The product was distributed nationwide in the United States.

The recall is being issued due to lack of assurance of sterility of the compounded product. This issue involves the manufacturing process for the injectable medication.

Healthcare facilities and practitioners that received this product should discontinue use of affected lots and contact Nephron Sterile Compounding Center LLC for return and replacement guidance.

The recalled product

Product: Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500…
Manufacturer: Nephron Sterile Compounding Center LLC
Category: Drug — Injectable Compounded
Hazard: lack-of-sterility
Affected units: 2,210

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 (3)

Lots: RP2003A
Exp. 7/20/2022
RP2003B

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 37 recalled by Nephron Sterile Compounding Center 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 37 products in this recall →

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · lack of sterility