FDAClass IIOctober 30, 2019

Amino Acid Injection recall: Sterility Concern

Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility…

Why was Amino Acid Injection recalled?

Lack of Assurance of Sterility; bags have potential to leak

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: AA9023A Exp. 10/24/2019; AA9023B Exp. 10/24/2019

Product
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility…
Recalling firm
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Quantity
162 bags
Distribution
Nationwide.
Recall date
October 30, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls