FDA (Drugs) recall action 90512

Nephron Sterile Compounding Center LLC recalled 37 products on 2022-07-27

The FDA (Drugs) publishes a recall like this one as 37 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 37 pages.

Products: 37
Announced: 2022-07-27
Critical: 0
Units: 1,616,777

Why these products were recalled

Lack of Assurance of Sterility

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–37 of 37

HighFDA (Drugs)··2022-07-27
Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
Nephron is recalling Phenylephrine HCl Injection syringes due to lack of assurance of sterility. Approximately 75,630 syringes distributed nationwide are affected.
Product
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10
Category
Distribution
0 states
HighFDA (Drugs)··2022-07-27
Atropine Sulfate Injection Recalled Nationwide for Sterility Assurance Failure
Nephron Sterile Compounding Center LLC is recalling Atropine Sulfate Injection pre-filled syringes nationwide due to lack of assurance of sterility affecting approximately 13,340 syringes.
Product
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 outsourcing facility 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-935-03
Category
Distribution
0 states
HighFDA (Drugs)··2022-07-27
Ketamine HCl Injection Syringes Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Ketamine HCl Injection pre-filled syringes due to lack of assurance of sterility. The recall affects 30,745 syringes distributed nationwide.
Product
Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33
Category
Distribution
0 states
HighFDA (Drugs)··2022-07-27
HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance
HYDROmorphone HCl Injection 30 mg/30 mL from Nephron Sterile Compounding Center LLC is being recalled nationwide due to lack of assured sterility. The recall affects 18,570 syringes across three lot numbers.
Product
HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-30
Category
Distribution
0 states
HighFDA (Drugs)··2022-07-27
Neostigmine Methylsulfate Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The recall affects 59,520 syringes distributed nationwide.
Product
Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 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 outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-932-03
Category
Distribution
0 states
HighFDA (Drugs)··2022-07-27
Bupivacaine Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 6900 syringes of Bupivacaine HCl Injection nationwide due to lack of sterility assurance. No illnesses or injuries have been reported.
Product
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 503B outsourcing facility, 4500 12th St. Ext., West Columbia, SC 29172, NDC: 69374-970-50
Category
Distribution
0 states
HighFDA (Drugs)··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.
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
Category
Distribution
0 states
HighFDA (Drugs)··2022-07-27
Ketamine HCl Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Ketamine HCl Injection due to lack of sterility assurance. The recall affects 91,445 pre-filled syringes distributed nationwide.
Product
Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
Category
Distribution
0 states
HighFDA (Drugs)··2022-07-27
Morphine Sulfate Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 8,985 syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-30
Category
Distribution
0 states
HighFDA (Drugs)··2022-07-27
Glycopyrrolate Syringes Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 3450 glycopyrrolate injection syringes (NDC 69374-903-30, Lot GL2004A) nationwide due to lack of assurance of sterility.
Product
Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-30
Category
Distribution
0 states
HighFDA (Drugs)··2022-07-27
HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center recalled 22,805 pre-filled syringes of HYDROmorphone HCl Injection due to lack of sterility assurance. Six lot numbers were distributed nationwide.
Product
HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50
Category
Distribution
0 states
HighFDA (Drugs)··2022-07-27
Lidocaine HCl injection syringes recalled due to sterility assurance failure
Nephron Sterile Compounding Center has recalled 37,310 syringes of Lidocaine HCl Injection USP 1% nationwide due to lack of assurance of sterility. Affected lots expire between August and October 2022.
Product
Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-985-05
Category
Distribution
0 states