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.

1–25 of 37

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
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0 states
HighFDA (Drugs)··2022-07-27
Lidocaine HCl Injection Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center recalls Lidocaine HCl Injection 2% syringes distributed nationwide due to lack of assurance of sterility. Affected lots should not be used.
Product
Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 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: 69374-949-05
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0 states
HighFDA (Drugs)··2022-07-27
FDA Recalls HYDROmorphone Injection Syringes Due to Sterility Concerns
Nephron Sterile Compounding Center is recalling 3,740 HYDROmorphone injection syringes due to lack of assurance of sterility. The affected lot was distributed nationwide.
Product
HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 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. Extension, West Columbia, SC 29172, NDC: 69374-559-50
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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
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0 states
HighFDA (Drugs)··2022-07-27
Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 18,840 syringes of Succinylcholine Chloride Injection nationwide because the manufacturing process cannot be assured to have maintained sterility.
Product
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/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: 69374-919-10
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0 states
HighFDA (Drugs)··2022-07-27
Compounded Sterile Injectable Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling 2210 syringes of a three-drug compounded injectable due to lack of assurance of sterility.
Product
Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, 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
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0 states
HighFDA (Drugs)··2022-07-27
Sodium Bicarbonate Injection USP recalled for lack of sterility assurance
Nephron Sterile Compounding Center recalls 36,354 pre-filled syringes of Sodium Bicarbonate Injection due to lack of sterility assurance. The medication was distributed nationwide.
Product
8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
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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
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0 states
HighFDA (Drugs)··2022-07-27
Neostigmine Methylsulfate Injection recalled due to sterility assurance failure
Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The recall affects 10,700 syringes distributed nationwide.
Product
Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 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: 69374-942-04
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0 states
HighFDA (Drugs)··2022-07-27
Morphine Sulfate Injection Recalled Due to Sterility Assurance Concerns
Nephron Sterile Compounding Center LLC is recalling morphine sulfate injection syringes due to lack of assurance of sterility. The recall affects 4,620 pre-filled syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 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: 69374-979-01
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0 states
HighFDA (Drugs)··2022-07-27
Nephron Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection (1 mg/10 mL) syringes nationwide due to inability to guarantee sterility. Approximately 464,265 syringes across eleven lot numbers are affected.
Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 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: 69374-957-10
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0 states
HighFDA (Drugs)··2022-07-27
Neostigmine Methylsulfate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 64,365 syringes of Neostigmine Methylsulfate Injection nationwide due to lack of assurance of sterility. Patients using affected lots should contact their healthcare provider.
Product
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 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: 69374-902-05
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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
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0 states
HighFDA (Drugs)··2022-07-27
Morphine Sulfate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection syringes distributed nationwide due to lack of assurance of sterility. Approximately 43,385 syringes are affected.
Product
Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 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: 69374-979-02
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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
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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
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0 states
HighFDA (Drugs)··2022-07-27
Morphine Sulfate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 5,495 pre-filled syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, 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. Extension, West Columbia, SC 29172, NDC: 69374-979-50
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0 states
HighFDA (Drugs)··2022-07-27
Glycopyrrolate Injection Recalled for Lack of Sterility Assurance
Nephron is recalling Glycopyrrolate Injection pre-filled syringes distributed nationwide due to lack of sterility assurance. The recall affects 3,690 syringes from lot GL2001A, expiration 7/15/2022.
Product
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 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: 69374-903-05
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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
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0 states
HighFDA (Drugs)··2022-07-27
Epinephrine Injection Recalled Due to Sterility Assurance Failure
Nephron is recalling epinephrine injection syringes nationwide due to lack of sterility assurance. No illnesses have been reported to date.
Product
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 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: 69374-544-10
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0 states
HighFDA (Drugs)··2022-07-27
Oxytocin Injectable Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Oxytocin 30 Units/500 mL injectable solution due to lack of sterility assurance. Approximately 1,810 bags with lot codes OX2013C and OX2013E were distributed nationwide.
Product
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50
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0 states
HighFDA (Drugs)··2022-07-27
Epinephrine Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 134,385 epinephrine injection syringes nationwide due to lack of assurance of sterility. No illnesses have been reported.
Product
EPINEPHrine Injection, USP, 1 mg/10 mL (100 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: 69374-925-10
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0 states
HighFDA (Drugs)··2022-07-27
Ketamine HCl Injection Recalled for Lack of Sterility Assurance
Nephron is recalling 47,905 pre-filled syringes of Ketamine HCl Injection nationwide due to lack of sterility assurance. Users should contact the manufacturer for handling instructions.
Product
Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 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: 69374-511-01
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0 states
HighFDA (Drugs)··2022-07-27
Injectable Lidocaine Syringes Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center has recalled 1,380 prefilled lidocaine syringes nationwide due to inability to confirm product sterility.
Product
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 case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC:
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HighFDA (Drugs)··2022-07-27
Compounded Injectable Medications Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 2,315 pre-filled syringes due to lack of sterility assurance. The compounded injectable medication was distributed nationwide.
Product
Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 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. E
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