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Nephron Sterile Compounding Center LLC recall records

0 reported ongoing

73 records in this archive. Latest source date Feb 10, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

Feb 10, 2025FDA drug enforcement

Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50

Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.

Class IIReported terminated

Distribution: US Nationwide.

Official source

Feb 22, 2023FDA drug enforcement

Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Ou...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Feb 22, 2023FDA drug enforcement

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Neph...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Feb 22, 2023FDA drug enforcement

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, N...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Feb 22, 2023FDA drug enforcement

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, ...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Feb 22, 2023FDA drug enforcement

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Feb 22, 2023FDA drug enforcement

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, ...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Feb 22, 2023FDA drug enforcement

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, ...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Feb 22, 2023FDA drug enforcement

Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Neph...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Jan 6, 2023FDA drug enforcement

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, W...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA.

Official source

Nov 10, 2022FDA drug enforcement

PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3...

CGMP Deviations: Potential for cross contamination due to product carry over.

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Nov 10, 2022FDA drug enforcement

PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-93...

CGMP Deviations: Potential for cross contamination due to product carry over.

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Aug 10, 2022FDA drug enforcement

PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsou...

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Aug 10, 2022FDA drug enforcement

Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx...

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Aug 10, 2022FDA drug enforcement

PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Stree...

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Aug 10, 2022FDA drug enforcement

PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facil...

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Jun 30, 2022FDA drug enforcement

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

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Jun 30, 2022FDA drug enforcement

Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsou...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Jun 30, 2022FDA drug enforcement

0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Jun 30, 2022FDA drug enforcement

0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per ca...

Lack of Assurance of Sterility

Class IIReported terminated

Distribution: Nationwide in the USA

Official source

Reasons in these listed records

Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Lack of Assurance of Sterility
CGMP Deviations: Potential for cross contamination due to product carry over.
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

These examples come from this result page and are not a ranking of every recall reason.

Checking Nephron Sterile Compounding Center LLC

Is there a recall on nephron sterile compounding center llc right now?

This archive contains 73 records, including 0 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

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A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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