Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 36 of 251
Pharmacy Innovations
Class II Terminated
Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0207-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
Edetate Calcium Disodium 400MG/ML (30ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0203-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 100MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 15MCG/8.7MG/0.1MG/1.8MG...
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0227-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0199-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
PROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 20MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 22.5MCG/ML (1ML VIAL) INJECTABLE PROSTA...
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0234-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED 14MG/ML (3ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED-STS- 50MG/ML OPH SOLUTION VANCOMYCIN-STS- 25MG/ML (2ML DROPTA...
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0241-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT (1ML) 10M...
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0228-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0225-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
KETAMINE 50MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0216-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0214-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0192-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 4MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 5.4MG/ML (0.5M...
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0236-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
Hydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0187-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
Estradiol 0.05% OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0205-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML (1ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0202-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
VORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0243-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
LEVEMIR-STS- 100U/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0217-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0229-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/METHYLCOBAL 15MG/50MG/100MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/RIBOFLA/NIACINAMI...
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0220-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0219-2023 February 1, 2023 Erie, PA
Northern VA Compounders PLLC
Class II Terminated
Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Reason: Lack of Assurance of Sterility
D-0111-2023 January 18, 2023 Sterling, VA
Northern VA Compounders PLLC
Class II Terminated
Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Reason: Lack of Assurance of Sterility
D-0102-2023 January 18, 2023 Sterling, VA
Northern VA Compounders PLLC
Class II Terminated
QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock...
Reason: Lack of Assurance of Sterility
D-0107-2023 January 18, 2023 Sterling, VA
Northern VA Compounders PLLC
Class II Terminated
QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Ha...
Reason: Lack of Assurance of Sterility
D-0108-2023 January 18, 2023 Sterling, VA
Northern VA Compounders PLLC
Class II Terminated
BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Reason: Lack of Assurance of Sterility
D-0125-2023 January 18, 2023 Sterling, VA