D-0049-2023 Class II Ongoing
FDA drug recall D-0049-2023 was initiated by Pharmacy Plus, Inc. dba Vital Care Compounder on October 7, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1 vial.
Recall Details
- Product Type
- Drugs
- Report Date
- November 9, 2022
- Initiation Date
- October 7, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 vial
Product Description
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
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.
Distribution Pattern
AL, LA, MS, and TN
Code Information
Lot: 65976, BUD: 10/27/2022