Status
Terminated
Drug Enforcement D-0234-2023
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Classification
Class II
Report Date
February 1, 2023
Termination Date
July 31, 2024
Product Information
- Product description
- 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) INJECTABLE PROSTAGLANDIN E1 40MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 44.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 45MCG/ML (3ML VIAL) INJECTABLE PROSTAGLANDIN E1 50MCG/ML (1ML VIAL) INJECTION PROSTAGLANDIN E1 60MCG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Product quantity
- N/A
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Pharmacy Innovations
- Address
-
2936 W 17th St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0234-2023
- Event ID
- 91332
- Recall initiation date
- December 22, 2022
- Center classification date
- January 26, 2023
- Code info
- t20221027@29 t20221020@25 t20221109@17 t20221118@8 t20221129@68 t20221027@11 t20221010@24 t20221010@61 t20221005@2 t20221024@22 t20221116@36 t20221004@12
- More code info
- —