D-0053-2023 Class II Ongoing
FDA drug recall D-0053-2023 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: 800.5 mL in unit dose vials.
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
- 800.5 mL in unit dose vials
Product Description
SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, 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
Lots: 65680, BUD: 10/11/2022; 66043, BUD: 10/15/2022; 66372, BUD: 10/23/2022; 66597, BUD: 10/29/2022