CLASS II Drug recall · Reported 8 Jun 2022 · FDA Enforcement Report

Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL recalled

Nephron Sterile Compounding Center is recalling Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL (100 mg/mL) Pre-Filled Syringe, distributed nationwide in the US. The recall was initiated on 18 May 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: CG1003A, Exp. 12/3/2022; CG2001A, Exp. 2/10/2023

Quantity recalled30180 syringes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0951-2022
FDA event ID: 90211
Recalling firm: Nephron Sterile Compounding Center, West Columbia, SC
Classification: Class II
Status: Terminated
Recall initiated: 18 May 2022
FDA classified: 27 May 2022
Reported: 8 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

18 May 2022	Recall initiated by company
27 May 2022	Classified by FDA	+9 days
8 Jun 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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 Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

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

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

19 other products · FDA event 90211

Reported	Class	Recall	Company	Reason	Where
8 Jun 2022	CLASS II	Epinephrine Injection, USP, 1 mg recalled by Nephron Sterile Compounding	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Phenylephrine HCl Injection, USP, 0.4 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Neostigmine Methylsulfate Injection, USP, 5 mg/ (1 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Glycopyrrolate Injection, USP, 0.6 mg/ (0.2 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Hydromorphone HCl Injection, USP, 6 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Ketamine Hydrochloride Injection, USP, 50 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Lidocaine HCl Injection, USP, 2%, 100 mg/ (20 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL (84 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Ketamine Hydrochloride Injection, USP, 30 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	EPINEPHrine Injection, USP, 0.1 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Rocuronium Bromide Injection, 50 mg/ (10 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Fentanyl Citrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Oxytocin/mL) in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Phenylephrine HCl Injection, USP, 0.8 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Phenylephrine HCl Injection, USP, 1 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Succinylcholine Chloride Injection, USP, 100 mg/ (20 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Glycopyrrolate Injection, USP, 1 mg/ (0.2 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022	CLASS II	Hydromorphone HCl Injection, USP, 50 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide

More recalls from Nephron Sterile Compounding Center

All 73

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025Drug	CLASS II	Sodium Chloride Injection 9%, USP, Single-Dose IV recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Phenylephrine HCl Injection, USP, 0.8 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Phenylephrine HCl Injection, USP, 0.4 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide

Other Calcium Gluconate recalls

All 8

Reported	Class	Recall	Company	Reason	Where
7 Nov 2018Drug	CLASS II	Calcium Gluconate 10%, 100 mg/mL Injectable recalled	Pharm D Solutions	Sterility	Nationwide
5 Sep 2018Drug	CLASS II	Calcium Gluconate injectable, 10% Single Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Calcium Gluconate 10% Injection recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
9 Dec 2015Drug	CLASS II	Calcium Gluconate 10% Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
16 Apr 2014Drug	CLASS I	Calcium Gluconate 10% for Injection, SDV, PF recalled	Zions RX Formulations Services	Sterility	AZ