Home / Recalls / Pharmacy Innovations / D-0238-2023

D-0238-2023 Class II Terminated

Recalled by Pharmacy Innovations — Erie, PA

Recall Details

Product Type
Drugs
Report Date
February 1, 2023
Initiation Date
December 22, 2022
Termination Date
July 31, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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/ANASTROZOLE-GS OIL- 200MG/1MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP/PROP(80/20)-GS OIL- 200MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-CS OIL-PF- 80MG/ML (0.7ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 100MG/ML (1.2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 150MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 150MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (2.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (3ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 20MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 20MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 300MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (2.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 75MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 75MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 80MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 80MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL-PF- 75MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-OLIVE OIL- 50MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 125MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 200MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 50MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL-PF- 80MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE ENAN-GS OIL-PF- 300MG/ML (0.4ML VIAL) INJECTABLE TESTOSTERONE-PF- 50MG/ML (5%) (1ML DROPTAINERS) OPHTHALMIC, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

t20221011@42 t20221011@36 t20221116@36 t20221117@11 t20221116@36 t20221117@11 t20221011@36 t20221108@24 t20221007@33 t20221116@36 t20221129@68 t20221011@36 t20221108@24 t20221116@36 t20221014@45 t20221116@54 t20221116@55 t20221011@36 t20221024@36 t20221004@38 t20221109@46 t20221027@6 t20221010@8 t20221109@42 t20221115@21 t20221010@50 t20221115@19 t20221116@36 t20221117@11 t20221010@25 t20221116@36 t20221017@7 t20221117@23 t20221116@36 t20221117@11 t20221103@11 t20221003@7 t20221024@58 t20221018@10 t20221011@1 t20221121@43 t20221027@38

Other recalls by Pharmacy Innovations

  • D-0202-2023 Class II — Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML (1ML vial) Injec (December 22, 2022)
  • D-0204-2023 Class II — EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution, Rx Only, Pharmacy Innov (December 22, 2022)
  • D-0233-2023 Class II — PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovatio (December 22, 2022)
  • D-0223-2023 Class II — MITOMYCIN 0.2MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.2MG/ML (1ML VIAL) (December 22, 2022)
  • D-0221-2023 Class II — METHOTREXATE INTRAVITREAL (1ML VIAL) 4MG/ML (400MCG/0.1ML) INJECTABLE, Rx Only, (December 22, 2022)
  • D-0213-2023 Class II — GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYCERI (December 22, 2022)
  • D-0215-2023 Class II — HYDROXOCOBALAMIN-PF- 1MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations (December 22, 2022)
  • D-0216-2023 Class II — KETAMINE 50MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 1 (December 22, 2022)
  • D-0198-2023 Class II — Cholecalciferol (Vitamin D3) 100,000U/ML Injectable, Rx Only, Pharmacy Innovatio (December 22, 2022)
  • D-0193-2023 Class II — Apomorphine HCL 2MG/ML (10ML vial) Injectable, Rx Only, Pharmacy Innovations, 29 (December 22, 2022)