Why it was recalled
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0238-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 22, 2022
- FDA report date
- Feb 1, 2023
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmacy Innovations
Original FDA data
Every field from FDA enforcement report D-0238-2023, exactly as published.
Show all FDA fields
- City
- Erie
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 91332
- Address
- 2936 W 17th St
- 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
- Postal code
- 16505-3929
- Report date
- Feb 1, 2023
- Product type
- Drugs
- Recall number
- D-0238-2023
- Classification
- Class II
- Recalling firm
- Pharmacy Innovations
- Termination date
- Jul 31, 2024
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 22, 2022
- Initial firm notification
- Telephone
- Center classification date
- Jan 26, 2023