Status
Ongoing
Drug Enforcement D-0028-2023
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
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Product Information
- Product description
- AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Product quantity
- 168 droptainers
- 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-0028-2023
- Event ID
- 90982
- Recall initiation date
- October 7, 2022
- Center classification date
- November 2, 2022
- Code info
- Lots: 65521, BUD: 10/15/2022; 65545, BUD: 10/15/2022; 65605, BUD: 10/16/2022; 65658, BUD: 10/17/2022; 65733, BUD: 10/21/2022; 65894, BUD: 10/24/2022; 66019, BUD: 10/28/2022; 66120, BUD: 10/30/2022; 66388, BUD: 11/6/2022; 66755, BUD: 11/14/2022; 66870, UD: 11/18/2022; 66928, BUD: 11/19/2022
- More code info
- —