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.

1–25 of 59

HighFDA (Drugs)··2023-02-01
Vancomycin Ophthalmic Solutions Recalled for Sterility Assurance Concerns
Pharmacy Innovations is recalling vancomycin fortified ophthalmic solutions nationwide due to lack of sterility assurance. FDA inspection revealed insanitary conditions at the manufacturing facility.
Product
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 DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Mitomycin Ophthalmic Solution Recalled Nationwide Over Sterility Assurance
Pharmacy Innovations is recalling Mitomycin 0.2mg/ml ophthalmic solution nationwide due to lack of sterility assurance following FDA facility inspection findings.
Product
MITOMYCIN 0.2MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.2MG/ML (1ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Injectable Drug Recall: Lack of Sterility Assurance at Manufacturing Facility
Pharmacy Innovations is recalling an injectable medication due to lack of sterility assurance caused by insanitary conditions at the manufacturing facility. Affected vials were distributed nationwide.
Product
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML (1ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
FDA Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns
Pharmacy Innovations is recalling Acetylcysteine 10% Ophthalmic Solution nationwide due to FDA-identified insanitary manufacturing conditions that compromise product sterility. Affected batches include codes t20221011@36 and t20221108@24.
Product
Acetylcysteine 10% Ophthalmic Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Buprenorphine Injectable Recalled Due to Sterility Assurance Concerns
Pharmacy Innovations is recalling Buprenorphine HCL 0.9 MG/ML injectable vials nationwide due to potential sterility issues discovered during FDA facility inspection. No illnesses have been reported.
Product
Buprenorphine HCL 0.9 MG/ML (25ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Pharmacy Innovations Progesterone Injectable Vial Recalled for Sterility Concerns
Pharmacy Innovations is recalling PROGESTERONE-GS OIL 100MG/ML injectable vials distributed nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.
Product
PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Methylcobalamin Injectable Recall Due to Facility Sterility Assurance Failure
Pharmacy Innovations is recalling injectable methylcobalamin products in multiple strengths due to lack of sterility assurance. FDA inspection revealed insanitary facility conditions that compromise product safety.
Product
METHYLCOBALAMIN 12.5MG/ML (1ML VIAL) INJECTABLE METHYLCOBALAMIN 25MG/ML (1.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 3MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (0.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 12.5MG/ML (1ML VIAL)…
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Injectable Hydroxocobalamin Recalled Due to Sterility Assurance Failure
Pharmacy Innovations is recalling Hydroxocobalamin 25MG/ML injectable vials nationwide due to insanitary facility conditions identified during FDA inspection that compromise sterility assurance.
Product
Hydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Injectable Magnesium Chloride Recalled Due to Facility Contamination Concerns
Pharmacy Innovations is recalling magnesium chloride hexahydrate injectable (5 mL vials) distributed nationwide due to insanitary facility conditions that compromise product sterility assurance.
Product
MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Lidocaine-PF Injectable Vials Recalled for Sterility Assurance Deficiency
Pharmacy Innovations is recalling Lidocaine-PF 5% injectable solution nationwide due to insanitary facility conditions that compromised sterility assurance, discovered during FDA inspection.
Product
LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Gentamicin Bladder Irrigation Solutions Recalled for Sterility Assurance Failure
Pharmacy Innovations is recalling Gentamicin bladder irrigation solutions due to FDA findings of insanitary facility conditions that compromised sterility assurance during manufacturing.
Product
GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION…
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Antibiotic Eye Drops Recalled for Sterility Assurance Failure
Pharmacy Innovations is recalling Tobramycin Fortified 15mg/mL Ophthalmic Solution nationwide due to insanitary facility conditions that compromised sterility assurance. Consumers should discontinue use and contact their healthcare provider.
Product
TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Phenol 10% Injectable Vials Recalled for Sterility Assurance Failure
Pharmacy Innovations recalls Phenol 10% injectable vials distributed nationwide due to insanitary conditions at the manufacturing facility that compromised sterility assurance.
Product
PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Semaglutide Injectable Vials Recalled for Lack of Sterility Assurance
Pharmacy Innovations is recalling Semaglutide injectable vials in multiple strengths distributed nationwide due to insanitary facility conditions compromising sterility. No illnesses have been reported.
Product
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 (0.5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Injectable ophthalmic drug recalled for sterility assurance failure
FDA is recalling BSS Plus/Lidocaine Opth 1% injectable syringes manufactured by Pharmacy Innovations due to lack of sterility assurance found during a facility inspection.
Product
BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Flurbiprofen eye drops recalled for insanitary facility conditions
Pharmacy Innovations is recalling Flurbiprofen 0.04% ophthalmic solution nationwide due to insanitary conditions at the manufacturing facility that compromise product sterility.
Product
FLURBIPROFEN -CORN OIL- 0.04% (3ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Edetate Calcium Disodium Injectable Recalled for Sterility Assurance Concerns
Pharmacy Innovations is recalling Edetate Calcium Disodium 400MG/ML injectable vials nationwide due to insanitary manufacturing conditions that compromise sterility assurance.
Product
Edetate Calcium Disodium 400MG/ML (30ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Minoxidil injectable recalled due to lack of sterility assurance
Pharmacy Innovations is recalling Minoxidil 0.75% injectable due to insanitary facility conditions identified during FDA inspection that could compromise product sterility.
Product
Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Ketamine 50mg/ml Injectable Vial Recalled for Sterility Concerns
Pharmacy Innovations is recalling Ketamine 50mg/ml injectable vials nationwide due to insanitary facility conditions that compromised sterility assurance.
Product
KETAMINE 50MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Injectable drug products recalled due to unsanitary manufacturing conditions
Pharmacy Innovations is recalling injectable PE1/PAPAV/ATROP/CHLORPROM drugs due to insanitary facility conditions that compromise product sterility. FDA inspection found conditions that do not ensure the safety of these injectable medications.
Product
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/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 30MCG/8.7MG/0.1MG/1.8MG/ML…
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
FDA Recalls Voriconazole Ophthalmic Solution for Sterility Assurance Failure
Pharmacy Innovations is recalling Voriconazole 10mg/ml ophthalmic solution nationwide because FDA inspection found insanitary facility conditions that compromised product sterility assurance.
Product
VORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Injectable Vitamin D3 Products Recalled for Lack of Sterility Assurance
Pharmacy Innovations is recalling injectable Vitamin D3 products nationwide due to insanitary facility conditions that compromised sterility assurance. No illnesses have been reported.
Product
VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Tacrolimus Ophthalmic Solutions Recalled for Sterility Assurance Issues
Pharmacy Innovations recalls Tacrolimus ophthalmic solutions nationwide due to potential sterility assurance issues from insanitary facility conditions found during FDA inspection.
Product
TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02% (10ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (15ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (5ML DROPPER) OPHTHALMIC TACROLIMUS-VET…
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Dutasteride Injectable Recalled for Lack of Sterility Assurance
Pharmacy Innovations is recalling Dutasteride 0.1% injectable vials nationwide due to FDA-identified insanitary facility conditions that compromised sterility assurance. Patients should consult their healthcare provider about this prescription medication.
Product
Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Distribution
0 states
HighFDA (Drugs)··2023-02-01
Multiple injectable medications recalled for sterility assurance concerns
Pharmacy Innovations recalls multiple injectable medications nationwide due to insanitary facility conditions compromising sterility assurance. FDA inspection revealed conditions creating risk to medication safety.
Product
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) 10MCG/30MG/2MG/ML INJECTABLE PE1/PAPAV/PHENT 10MCG/18MG/1MG/ML (1ML VIAL)…
Category
Distribution
0 states