Class II · Moderate risk Ongoing
FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo…
Reason Lack of Assurance of Sterility
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ…
Reason Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton…
Class II · Moderate risk Ongoing
Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00…
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Class II · Moderate risk Ongoing
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack…
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Class II · Moderate risk Terminated
LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack…
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Class II · Moderate risk Terminated
HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.