Agency classClass IIOur severity:High FDA (Drugs)·D-1245-2022·Announced 2022-07-27

Nephron Amino Acid Injection Bags Recalled for Lack of Sterility Assurance

Nephron Sterile Compounding Center is recalling 163 bags of Amino Acid Injection due to lack of assurance of sterility. Patients using this intravenous medication should contact their healthcare provider immediately.

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: FDA Class II recall of a sterile injectable product with lack of assurance of sterility. While no illnesses or injuries have been reported, sterility failure in compounded intravenous medications represents a significant risk of serious infection. This meets the 'High' criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling 163 bags of Amino Acid Injection 50 g/1000 mL (50 mg/mL), NDC 69374-988-10, Lot AA2012A, with expiration date 07/04/2022. This is a prescription injectable medication manufactured at their facility located at 4500 12th Extension, West Columbia, South Carolina.

The recall is due to lack of assurance of sterility. Injectable medications must be sterile to be safe for patient use. Sterility issues in compounded intravenous medications can potentially lead to serious infections or sepsis.

The affected product was distributed nationwide throughout the United States. Patients who have received this medication should contact their healthcare provider to discuss whether they may have been affected and what follow-up care, if any, may be appropriate.

Healthcare providers and patients in possession of the recalled lots should stop use immediately. Contact Nephron Sterile Compounding Center or your healthcare provider for instructions on product disposal and replacement options.

The recalled product

Product: Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10
Manufacturer: Nephron Sterile Compounding Center LLC
Category: Drug — Compounded Injectable
Hazard: lack-of-sterility
infection-risk
Affected units: 163

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 (2)

Lots: AA2012A
Exp. 07/04/2022

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