FDAClass IIJune 8, 2022

Calcium Gluconate Injection recall: Sterility Concern

Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe…

Why was Calcium Gluconate Injection recalled?

Lack of Assurance of Sterility

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: CG1003A, Exp. 12/3/2022; CG2001A, Exp. 2/10/2023

Product
Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe…
Recalling firm
Nephron Sterile Compounding Center LLC
Quantity
30180 syringes
Distribution
Nationwide in the USA
Recall date
June 8, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls