Status
Ongoing
Drug Enforcement D-0044-2023
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
1 Views
Classification
Class II
Report Date
November 9, 2022
Termination Date
—
Product Information
- Product description
- PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Product quantity
- 1 vial
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- AL, LA, MS, and TN
Location & Firm
- Recalling firm
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Address
-
115 S 40th Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0044-2023
- Event ID
- 90982
- Recall initiation date
- October 7, 2022
- Center classification date
- November 2, 2022
- Code info
- Lot: 65425, BUD: 10/13/2022
- More code info
- —