D-0047-2023 Class II Ongoing
FDA drug recall D-0047-2023 was initiated by Pharmacy Plus, Inc. Dba Vital Care Compounder on Oct 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: 28 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 9, 2022
- Initiation Date
- Oct 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 vials
Product Description
PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 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: 60552, BUD: 03/12/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0047-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026