The Recall Desk

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.

26–50 of 59

  • HighFDA (Drugs)··2023-02-01

    FDA Recalls Scopolamine Ophthalmic Solution for Sterility Assurance Issues

    Pharmacy Innovations recalled Scopolamine Hydrobromide 0.25% ophthalmic solution nationwide due to FDA inspection findings of insanitary facility conditions that compromise sterility assurance.

    Product
    SCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION, 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 (
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    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

    Ophthalmic solution recalled for lack of sterility assurance

    Pharmacy Innovations recalls a polyhexamethylene biguanide eye-drop solution nationwide due to insanitary manufacturing conditions. No illnesses have been reported.

    Product
    POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    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

    Pharmacy Innovations recalls injectable estradiol and testosterone products nationwide for sterility assurance

    Pharmacy Innovations recalls multiple injectable estradiol and testosterone products due to insanitary facility conditions that compromise sterility assurance. The products were distributed nationwide.

    Product
    ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP/TEST CYP -SS OIL- 2MG/25MG/ML (1ML VIAL) INJECTABLE; ESTRADIOL CYP-CS OIL- 5MG/ML (1.25ML VIAL) INJECTABLE; ESTRADIOL CYP-GS OIL- 5MG/ML (1ML VIAL) INJECTABLE ESTRADIOL CYP-SS OIL- 5MG/ML (1.5ML VI
    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 CYP/A
    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

    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

    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

    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

    Clindamycin/EDTA Calcium Irrigation Solution Recalled for Lack of Sterility Assurance

    Pharmacy Innovations is recalling Clindamycin/EDTA Calcium irrigation solution (30ML syringe) distributed nationwide due to lack of assurance of sterility caused by insanitary conditions found during FDA inspection.

    Product
    Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-01

    Injectable NADH Recalled for Sterility Concerns at Manufacturing Facility

    Pharmacy Innovations is recalling NADH 10MG/ML injectable vials distributed nationwide due to lack of assurance of sterility. FDA inspection revealed insanitary conditions at the facility.

    Product
    NADH 10MG/ML (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

    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

    Injectable hydroxocobalamin vials recalled due to sterility concerns

    Pharmacy Innovations is recalling hydroxocobalamin-PF injectable vials (1mg/ml) distributed nationwide because FDA inspection found insanitary conditions at the manufacturing facility that could compromise product sterility.

    Product
    HYDROXOCOBALAMIN-PF- 1MG/ML (1ML 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) I
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-02-01

    Pharmacy Innovations polidocanol injectable vials recalled for lack of sterility

    Pharmacy Innovations is recalling polidocanol injectable vials nationwide after FDA inspection revealed insanitary conditions at the manufacturing facility that compromised sterility assurance.

    Product
    POLIDOCANOL 50MG/ML (5%) (30ML VIAL) INJECTABLE, 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

    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

    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

    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

    FDA Recalls Mitomycin Ophthalmic Solution for Sterility Assurance Failure

    Pharmacy Innovations is recalling Mitomycin ophthalmic solutions nationwide due to a lack of sterility assurance. An FDA inspection found insanitary conditions at the manufacturing facility.

    Product
    MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIAL) OPH SOLUTION; MITOMYCIN 0.4MG/ML (4ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
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    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

    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