L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1515-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1528-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1532-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1525-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1522-2022September 21, 2022Ridgeland, SC
Carolina Infusion
Class IICompleted
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason: Lack of Assurance of Sterility
D-1517-2022September 21, 2022Ridgeland, SC
CIPLA
Class IITerminated
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Reason: Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
D-1499-2022September 14, 2022Warren, NJ
CIPLA
Class IITerminated
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
Reason: Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
D-1498-2022September 14, 2022Warren, NJ
Akorn, Inc.
Class IITerminated
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
Reason: cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root...
D-1495-2022September 14, 2022Gurnee, IL
Akorn, Inc.
Class IITerminated
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
Reason: cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root...
D-1496-2022September 14, 2022Gurnee, IL
CIPLA
Class IITerminated
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Reason: Lack of Assurance of Sterility: Complaints received of defective container closure.
D-1328-2022August 17, 2022Warren, NJ
SterRx, LLC
Class IITerminated
fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
Reason: Lack of Assurance of Sterility
D-1332-2022August 17, 2022Plattsburgh, NY
SterRx, LLC
Class IITerminated
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
Reason: Lack of Assurance of Sterility
D-1331-2022August 17, 2022Plattsburgh, NY
Nephron Sterile Compounding Center LLC
Class IITerminated
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 12t...
Reason: Lack of Assurance of Sterility
D-1264-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
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 Syri...
Reason: Lack of Assurance of Sterility
D-1249-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
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 12...
Reason: Lack of Assurance of Sterility
D-1263-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
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. Extensio...
Reason: Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
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, 4...
Reason: Lack of Assurance of Sterility
D-1270-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
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 facil...
Reason: Lack of Assurance of Sterility
D-1247-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 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 fac...
Reason: Lack of Assurance of Sterility
D-1280-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 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. Ex...
Reason: Lack of Assurance of Sterility
D-1256-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
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 ...
Reason: Lack of Assurance of Sterility
D-1259-2022July 27, 2022West Columbia, SC
Nephron Sterile Compounding Center LLC
Class IITerminated
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 12t...