FDA (Drugs) recall action 91332

Pharmacy Innovations recalled 59 products on 2023-02-01

The FDA (Drugs) publishes a recall like this one as 59 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 59 pages.

Products: 59
Announced: 2023-02-01
Critical: 0
Units: —

Why these products were recalled

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

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

51–59 of 59

HighFDA (Drugs)··2023-02-01
Injectable vitamin B-complex products recalled for lack of sterility assurance
Pharmacy Innovations is recalling three injectable vitamin B-complex products nationwide due to insanitary conditions discovered during FDA inspection. The products lack assurance of sterility and may pose contamination risk.
Product
THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML (3ML VIAL) INJECTABLE THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/METHYLFOLATE/METHYLCOBAL 10MG/2.5MG/25MG/5MG/5MG/10MG/10MG/ML (1ML VIAL) INJECTABLE…
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Pharmacy Innovations Methylcobalamin Injectable Solutions Recalled for Sterility Concerns
Pharmacy Innovations is recalling Methylcobalamin injectable solutions (1MG/ML, 3MG/ML, 5MG/ML vials) distributed nationwide. FDA inspection revealed insanitary conditions at the facility affecting product sterility assurance.
Product
Methylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylcobalamin 5MG/ML (1ML vial) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Pharmacy Innovations Testosterone Injectables and Ophthalmic Products Recalled for Sterility Concerns
Pharmacy Innovations is recalling multiple testosterone injectable and ophthalmic formulations nationwide due to insanitary facility conditions that prevent assurance of sterile manufacturing.
Product
TESTOSTERONE 3% (4GM TUBE) OPHTH OINTME TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/0.5MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (3ML VIAL) INJECTABLE TESTOSTERONE…
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Edetate Disodium Ophthalmic Solution Recalled for Sterility Concerns
Pharmacy Innovations is recalling Edetate Disodium 1% ophthalmic solution nationwide due to insanitary facility conditions that compromised sterility assurance. No illnesses have been reported.
Product
EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Injectable Ethyl Alcohol 95% Recalled Due to Sterility Assurance Concerns
Pharmacy Innovations is recalling Ethyl Alcohol 95% (5ML vial) Injectable nationwide because FDA inspection revealed insanitary conditions at the manufacturing facility that compromise sterility assurance.
Product
Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Injectable Prostaglandin E1 Multiple Strengths Recalled for Sterility Concerns
Pharmacy Innovations is recalling multiple strengths of injectable Prostaglandin E1 nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.
Product
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 PROSTAGLANDIN E1 23MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 30MCG/ML (1ML VIAL)…
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Albuterol Inhalation Solution Recalled for Lack of Sterility Assurance
Pharmacy Innovations is recalling nationwide Albuterol 0.083% inhalation solution in 3ML tubes due to insanitary manufacturing facility conditions that compromise sterility assurance.
Product
Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Pharmacy Innovations Recalls Heparin Irrigation Solution Due to Sterility Concerns
Pharmacy Innovations is recalling a heparin-lidocaine irrigation solution nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.
Product
HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
FDA Recalls Injectable Glycerin 72% Due to Sterility Assurance Failure
Pharmacy Innovations is recalling Injectable Glycerin 72% (15mL vials) nationwide due to lack of sterility assurance discovered during FDA facility inspection.
Product
GLYCERIN 72% (W/V) (15ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states